CSMS# 18-000516 - FDA New and End-dated CDRH Product Codes
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09/04/2018 05:15 PM EDT
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The Food and Drug Administration has created new product codes, which will be available in 60 days on November 5, 2018. The Food and Drug Administration is also end-dating product codes, effective in 60 days November 5, 2018. The new and end-dated codes are described below.
End-Dated Code/Description
74D--WM/Apparatus, Suction, Patient Care
New Code/Description
73D--WM / Apparatus, Suction, Patient Care
End-Dated Code/Description
84G--ZE / Stimulator, Diaphragmatic/Phrenic Nerve, Implanted
New Code/Description
73G--ZE / Stimulator, Diaphragmatic/Phrenic Nerve, Implanted
End-Dated Code/Description
74P--GJ / Oximeter, wellness
New Code/Description
73P--GJ / Oximeter, wellness
End-Dated Code/Description
82J--MG / Radioimmunoassay (Two-Site Solid Phase), Ferritin
New Code/Description
75J--MG / Radioimmunoassay (Two-Site Solid Phase), Ferritin
End-Dated Code/Description
91P--HV / Continuous glucose monitor retrospective data analysis software
New Code/Description
75P--HV / Continuous glucose monitor retrospective data analysis software
End-Dated Code/Description
77O--HP / Expiratory resistance valve, intranasal, for obstructive sleep apnea
New Code/Description
76O--HP / Expiratory resistance valve, intranasal, for obstructive sleep apnea
End-Dated Code/Description
84G--ZD / Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation
New Code/Description
78G--ZD / Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation
End-Dated Code/Description
85H--IR / Perineometer
New Code/Description
78H--IR / Perineometer
End-Dated Code/Description
74M--NW / Analyzer, Body Composition
New Code/Description
78M--NW / Analyzer, Body Composition
End-Dated Code/Description
85O--TN / Mesh, surgical, gynecologic, for stress urinary incontinence, female
New Code/Description
78O--TN / Mesh, surgical, gynecologic, for stress urinary incontinence, female
End-Dated Code/Description
80O--ZW / Ingestible event marker
New Code/Description
78O--ZW / Ingestible event marker
End-Dated Code/Description
85P--AG / Mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, female, multi-incisi
New Code/Description
78P--AG / Mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, female, multi-incisi
End-Dated Code/Description
85P--AH / Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, single-incision
New Code/Description
78P--AH / Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, single-incision
End-Dated Code/Description
74P--UH / Analyzer, body composition, exempt
New Code/Description
78P--UH / Analyzer, body composition, exempt
End-Dated Code/Description
85P--WJ / Instrumentation, surgical mesh, urogynecologic, stress urinary incontinence
New Code/Description
78P--WJ / Instrumentation, surgical mesh, urogynecologic, stress urinary incontinence
End-Dated Code/Description
78E--XM / Truss, Umbilical
New Code/Description
79E--XM / Truss, Umbilical
End-Dated Code/Description
78E--YN / Tray, Irrigation, Sterile
New Code/Description
79E--YN / Tray, Irrigation, Sterile
End-Dated Code/Description
78F--BQ / Trocar, Gastro-Urology
New Code/Description
79F--BQ / Trocar, Gastro-Urology
End-Dated Code/Description
78F--DP / Apparatus, Pneumoperitoneum, Automatic
New Code/Description
79F--DP / Apparatus, Pneumoperitoneum, Automatic
End-Dated Code/Description
78F--SH / Tray, surgical, needle
New Code/Description
79F--SH / Tray, surgical, needle
End-Dated Code/Description
78G--CG / Peritoneoscope
New Code/Description
79G--CG / Peritoneoscope
End-Dated Code/Description
78G--CH / Mediastinoscope
New Code/Description
79G--CH / Mediastinoscope
End-Dated Code/Description
78G--CI / Laryngoscope
New Code/Description
79G--CI / Laryngoscope
End-Dated Code/Description
74M--VR / Device, Anastomotic, Microvascular
New Code/Description
79M--VR / Device, Anastomotic, Microvascular
End-Dated Code/Description
89N--ZF / Massager, cosmetic, static electricity-emitting
New Code/Description
79N--ZF / Massager, cosmetic, static electricity-emitting
End-Dated Code/Description
84N--ZY / Light, lymphadema reduction, low energy
New Code/Description
79N--ZY / Light, lymphadema reduction, low energy
End-Dated Code/Description
84O--NA / Stereotaxic instrument
New Code/Description
79O--NA / Stereotaxic instrument
End-Dated Code/Description
80P--BZ / Surgical sponge visual scale
New Code/Description
79P--BZ / Surgical sponge visual scale
End-Dated Code/Description
78P--HU / Intra-abdominal pressure monitoring device
New Code/Description
79P--HU / Intra-abdominal pressure monitoring device
End-Dated Code/Description
73C--AH / Filter, Bacterial, Breathing-Circuit
New Code/Description
80C--AH / Filter, Bacterial, Breathing-Circuit
End-Dated Code/Description
74D--QF / Actuator, Syringe, Injector Type
New Code/Description
80D--QF / Actuator, Syringe, Injector Type
End-Dated Code/Description
74D--QI / Pump, Withdrawal/Infusion
New Code/Description
80D--QI / Pump, Withdrawal/Infusion
End-Dated Code/Description
79E--YX / Drape, Pure Latex Sheet, With Self-Retaining Finger Cot
New Code/Description80E--YX / Drape, Pure Latex Sheet, With Self-Retaining Finger Cot
End-Dated Code/Description
79E--YY / Drape, Urological, Disposable
New Code/Description
80E--YY / Drape, Urological, Disposable
End-Dated Code/Description
79F--IJ / System, Dialysate Delivery, Recirculating, Single Pass
New Code/Description
80F--IJ / System, Dialysate Delivery, Recirculating, Single Pass
End-Dated Code/Description
79F--RT / Unit, Isolation, Surgical
New Code/Description
80F--RT / Unit, Isolation, Surgical
End-Dated Code/Description
79F--XO / Suit, Surgical
New Code/Description
80F--XO / Suit, Surgical
End-Dated Code/Description
79F--XP / Cover, Shoe, Operating-Room
New Code/Description
80F--XP / Cover, Shoe, Operating-Room
End-Dated Code/Description
79F--XX / Mask, Surgical
New Code/Description
80F--XX / Mask, Surgical
End-Dated Code/Description
79F--XY / Hood, Surgical
New Code/Description
80F--XY / Hood, Surgical
End-Dated Code/Description
79F--XZ / Helmet, Surgical
New Code/Description
80F--XZ / Helmet, Surgical
End-Dated Code/Description
79F--YA / Gown, Surgical
New Code/Description
80F--YA / Gown, Surgical
End-Dated Code/Description
79F--YB / Gown, Patient
New Code/Description
80F--YB / Gown, Patient
End-Dated Code/Description
79F--YC / Gown, Isolation, Surgical
New Code/Description
80F--YC / Gown, Isolation, Surgical
End-Dated Code/Description
79F--YD / Apparatus, Exhaust, Surgical
New Code/Description
80F--YD / Apparatus, Exhaust, Surgical
End-Dated Code/Description
79F--YH / Splint, Extremity, Noninflatable, External
New Code/Description
80F--YH / Splint, Extremity, Noninflatable, External
End-Dated Code/Description
79H--MT / Drape, Patient, Ophthalmic
New Code/Description
80H--MT / Drape, Patient, Ophthalmic
End-Dated Code/Description
79H--MW / Drape, Microscope, Ophthalmic
New Code/Description
80H--MW / Drape, Microscope, Ophthalmic
End-Dated Code/Description
89I--QG / Adaptor, Holder, Syringe
New Code/Description
80--QG / Adaptor, Holder, Syringe
End-Dated Code/Description
79K--GO / Surgeon's Gloves
New Code/Description
80K--GO / Surgeon's Gloves
End-Dated Code/Description
79K--GQ / Cream, Gloving, Surgeon's
New Code/Description
80K--GQ / Cream, Gloving, Surgeon's
End-Dated Code/Description
79K--GT / Drape, Adhesive, Aerosol
New Code/Description
80K--GT / Drape, Adhesive, Aerosol
End-Dated Code/Description
79K--KX / Drape, Surgical
New Code/Description
80K--KX / Drape, Surgical
End-Dated Code/Description
79K--KY / Material, Polytetrafluoroethylene Vitreous Carbon for Maxillofacial Reconstruction
New Code/Description
80K--KY / Material, Polytetrafluoroethylene Vitreous Carbon for Maxillofacial Reconstruction
End-Dated Code/Description
79L--YU / Accessory, Surgical Apparel
New Code/Description
80L--YU / Accessory, Surgical Apparel
End-Dated Code/Description
79M--AC / Decontamination kit
New Code/Description
80M--AC / Decontamination kit
End-Dated Code/Description
79N--DC / Calculator, Drug Dose
New Code/Description
80N--DC / Calculator, Drug Dose
End-Dated Code/Description
89N--XB / Dispenser, solid medication
New Code/Description
80N--XB / Dispenser, solid medication
End-Dated Code/Description
74O--FM / Phlebotomy blood collection kit
New Code/Description
80O--FM / Phlebotomy blood collection kit
End-Dated Code/Description
89O--JL / insulin vial protector/holder
New Code/Description
80O--JL / insulin vial protector/holder
End-Dated Code/Description
79O--PA / Powder-free synthetic/non-latex surgeon's gloves
New Code/Description
80O--PA / Powder-free synthetic/non-latex surgeon's gloves
End-Dated Code/Description
79O--VR / Kit, first aid, talking
New Code/Description
80O--VR / Kit, first aid, talking
End-Dated Code/Description
82D--BT / Factor Xiii A, S, Antigen, Antiserum, Control
New Code/Description
81D--BT / Factor Xiii A, S, Antigen, Antiserum, Control
End-Dated Code/Description
82D--DE / Carbonic Anhydrase C, Antigen, Antiserum, Control
New Code/Description
81D--DE / Carbonic Anhydrase C, Antigen, Antiserum, Control
End-Dated Code/Description
82D--DF / Prothrombin, Antigen, Antiserum, Control
New Code/Description
81D--DF / Prothrombin, Antigen, Antiserum, Control
End-Dated Code/Description
82D--DH / Carbonic Anhydrase B, Antigen, Antiserum, Control
New Code/Description
81D--DH / Carbonic Anhydrase B, Antigen, Antiserum, Control
End-Dated Code/Description
82D--DX / Plasminogen, Antigen, Antiserum, Control
New Code/Description
81D--DX / Plasminogen, Antigen, Antiserum, Control
End-Dated Code/Description
82D--GB / Seminal Fluid, Antigen, Antiserum, Control
New Code/Description
81D--GB / Seminal Fluid, Antigen, Antiserum, Control
End-Dated Code/Description
82D--GQ / Whole Blood Plasma, Antigen, Antiserum, Control
New Code/Description
81D--GQ / Whole Blood Plasma, Antigen, Antiserum, Control
End-Dated Code/Description
82D--GR / Whole Human Serum, Antigen, Antiserum, Control
New Code/Description
81D--GR / Whole Human Serum, Antigen, Antiserum, Control
End-Dated Code/Description
88G--JH / Stain, Reticulocyte
New Code/Description
81G--JH / Stain, Reticulocyte
End-Dated Code/Description
88G--JJ / Stains, Heinz Body
New Code/Description
81G--JJ / Stains, Heinz Body
End-Dated Code/Description
88G--JL / Romanowsky Stains
New Code/Description
81G--JL / Romanowsky Stains
End-Dated Code/Description
88I--AZ / Heparin
New Code/Description
81I--AZ / Heparin
End-Dated Code/Description
88I--FO / Solution, Newcomer's
New Code/Description
81I--FO / Solution, Newcomer's
End-Dated Code/Description
88I--FS / Solution, Helly
New Code/Description
81I--FS / Solution, Helly
End-Dated Code/Description
88I--GK / Solution, Clarke's
New Code/Description
81I--GK / Solution, Clarke's
End-Dated Code/Description
88I--JZ / Oil, Clearing
New Code/Description
81I--JZ / Oil, Clearing
End-Dated Code/Description
82K--TK / Reagent, Immunoassay, Carbonic Anhydrase B and C
New Code/Description
81K--TK / Reagent, Immunoassay, Carbonic Anhydrase B and C
End-Dated Code/Description
88L--KM / Counter, Urine Particle
New Code/Description
81L--KM / Counter, Urine Particle
End-Dated Code/Description
85M--NA / Device, Semen Analysis
New Code/Description
81M--NA / Device, Semen Analysis
End-Dated Code/Description
82O--VQ / Chronic lymphocytic leukemia fish probe kit
New Code/Description
81O--VQ / Chronic lymphocytic leukemia fish probe kit
End-Dated Code/Description
82P--CZ / Investigational use only - Immunology
New Code/Description
81P--CZ / Investigational use only - Immunology
End-Dated Code/Description
73P--HY / Sparse sample PK profile and dosing software
New Code/Description
81P--HY / Sparse sample PK profile and dosing software
End-Dated Code/Description
88I--BB / Phytohemaglutinin M
New Code/Description
82I--BB / Phytohemaglutinin M
End-Dated Code/Description
88K--EF / Paraformaldehyde
New Code/Description
82K--EF / Paraformaldehyde
End-Dated Code/Description
81K--EX / Sorter, Cell
New Code/Description
82K--EX / Sorter, Cell
End-Dated Code/Description
81L--IZ / Assay, T Lymphocyte Surface Marker
New Code/Description
82L--IZ / Assay, T Lymphocyte Surface Marker
End-Dated Code/Description
81L--JD / Assay, B Lymphocyte Marker
New Code/Description
82L--JD / Assay, B Lymphocyte Marker
End-Dated Code/Description
81M--AN / Assay, Interleukin
New Code/Description
82M--AN / Assay, Interleukin
End-Dated Code/Description
81P--DX / Flow cytometry calibrator
New Code/Description
82P--DX / Flow cytometry calibrator
End-Dated Code/Description
83P--JI / Severe combined immunodeficiency disorder (SCID) Newborn Screening Test System
New Code/Description
82P--JI / Severe combined immunodeficiency disorder (SCID) Newborn Screening Test System
End-Dated Code/Description
82O--UY / TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM
New Code/Description
83O--UY / TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM
End-Dated Code/Description
73B--WK / Stimulator, Electro-Acupuncture
New Code/Description
84B--WK / Stimulator, Electro-Acupuncture
End-Dated Code/Description
89I--KN / Electromyograph, Diagnostic
New Code/Description
84I--KN / Electromyograph, Diagnostic
End-Dated Code/Description
89I--KT / Electrode, Needle, Diagnostic Electromyograph
New Code/Description
84I--KT / Electrode, Needle, Diagnostic Electromyograph
End-Dated Code/Description
89M--LQ / Inhibitor, Peridural Fibrosis (Adhesion Barrier)
New Code/Description
84M--LQ / Inhibitor, Peridural Fibrosis (Adhesion Barrier)
End-Dated Code/Description
87O--AN / orthosis, cranial, laser scan
New Code/Description
84O--AN / orthosis, cranial, laser scan
End-Dated Code/Description
77O--RR / Neurological stereotaxic instrument, real-time intraoperative mri
New Code/Description
84O--RR / Neurological stereotaxic instrument, real-time intraoperative mri
End-Dated Code/Description
89O--TX / Foot wrap for treating restless leg syndrome symptoms
New Code/Description
84O--TX / Foot wrap for treating restless leg syndrome symptoms
End-Dated Code/Description
89O--VP / Vibratory counter-stimulation
New Code/Description
84O--VP / Vibratory counter-stimulation
End-Dated Code/Description
89O--ZJ / Inhibitor, postoperative fibrosis (adhesion barrier)
New Code/Description
84O--ZJ / Inhibitor, postoperative fibrosis (adhesion barrier)
End-Dated Code/Description
89P--CQ / Inhibitor, postoperative fibrosis (spine adhesion barrier)
New Code/Description
84P--CQ / Inhibitor, postoperative fibrosis (spine adhesion barrier)
End-Dated Code/Description
89P--HL / Powered Exoskeleton
New Code/Description
84P--HL / Powered Exoskeleton
End-Dated Code/Description
78M--CI / Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite
New Code/Description
85M--CI / Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite
End-Dated Code/Description
90N--RZ / Ablation System, High intensity focused Ultrasound (HIFU), MR-Guided
New Code/Description
85N--RZ / Ablation System, High intensity focused Ultrasound (HIFU), MR-Guided
End-Dated Code/Description
74O--SV / Insfufflator, endoscopic vessel harvesting
New Code/Description
85O--SV / Insfufflator, endoscopic vessel harvesting
End-Dated Code/Description
90P--AS / RF/Microwave hyperthermia system, cancer treatment
New Code/Description
85P--AS / RF/Microwave hyperthermia system, cancer treatment
End-Dated Code/Description
78P--SI / Perineal irrigation kit
New Code/Description
85P--SI / Perineal irrigation kit
End-Dated Code/Description
79J--DJ / Prosthesis, Hip, Acetabular Mesh
New Code/Description
87J--DJ / Prosthesis, Hip, Acetabular Mesh
End-Dated Code/Description
79J--DK / Prosthesis, Hip, Cement Restrictor
New Code/Description
87J--DK / Prosthesis, Hip, Cement Restrictor
End-Dated Code/Description
89M--BP / Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
New Code/Description
87M--BP / Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
End-Dated Code/Description
89M--BS / Filler, Bone Void, Non-Osteoinduction
New Code/Description
87M--BS / Filler, Bone Void, Non-Osteoinduction
End-Dated Code/Description
89M--PW / Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
New Code/Description
87M--PW / Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
End-Dated Code/Description
84O--JP / orthopedic computer controlled surgical system
New Code/Description
87O--JP / orthopedic computer controlled surgical system
End-Dated Code/Description
84O--NN / intraoperative orthopedic joint assessment aid
New Code/Description
87O--NN / intraoperative orthopedic joint assessment aid
End-Dated Code/Description
82D--AA / Igg, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--AA / Igg, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--EP / Lambda, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--EP / Lambda, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--EY / Igm, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--EY / Igm, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--FD / Kappa, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--FD / Kappa, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--GH / Igd, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--GH / Igd, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--GO / Ige, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--GO / Ige, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--HF / D/Km-1, Antigen, Antiserum, Control
New Code/Description
88D--HF / D/Km-1, Antigen, Antiserum, Control
End-Dated Code/Description
81G--IA / Test, Leukocyte Peroxidase
New Code/Description
88G--IA / Test, Leukocyte Peroxidase
End-Dated Code/Description
82L--YE / Cytokeratins
New Code/Description
88L--YE / Cytokeratins
End-Dated Code/Description
81M--AO / DNA-Probe, Human Chromosome
New Code/Description
88M--AO / DNA-Probe, Human Chromosome
End-Dated Code/Description
81M--TI / Kit, Cell Screening, Fetal
New Code/Description
88M--TI / Kit, Cell Screening, Fetal
End-Dated Code/Description
82M--VD / System, Test, HER-2/NEU, Nucleic Acid or Serum
New Code/Description
88M--VD / System, Test, HER-2/NEU, Nucleic Acid or Serum
End-Dated Code/Description
81N--PQ / Test, Factor V Leiden Mutations, Genomic DNA PCR
New Code/Description
88N--PQ / Test, Factor V Leiden Mutations, Genomic DNA PCR
End-Dated Code/Description
81N--PR / Test, Factor II G20210A Mutations, Genomic DNA PCR
New Code/Description
88N--PR / Test, Factor II G20210A Mutations, Genomic DNA PCR
End-Dated Code/Description
82N--SD / Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for rec
New Code/Description
88N--SD / Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for rec
End-Dated Code/Description
82N--TH / System, Automated scanning microscope and image analysis for fluorescience in Situ Hybridization (Fi
New Code/Description
88N--TH / System, Automated scanning microscope and image analysis for fluorescience in Situ Hybridization (Fi
End-Dated Code/Description
82N--TW / System, Blood Collection, RNA Stabilization, RNA Purification, RT-PCR Molecular Diagnostic Test
New Code/Description
88N--TW / System, Blood Collection, RNA Stabilization, RNA Purification, RT-PCR Molecular Diagnostic Test
End-Dated Code/Description
82N--UA / System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detention
New Code/Description
88N--UA / System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detention
End-Dated Code/Description
82N--XG / Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
New Code/Description
88N--XG / Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
End-Dated Code/Description
82N--YI / Classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer
New Code/Description
88N--YI / Classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer
End-Dated Code/Description
82O--QS / Laboratory developed test
New Code/Description
88O--QS / Laboratory developed test
End-Dated Code/Description
82O--WE / Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
New Code/Description
88O--WE / Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
End-Dated Code/Description
82O--WM / Prostate-specific antigen (psa) for prognostic, recurrence risk assessment of prostate cancers
New Code/Description
88O--WM / Prostate-specific antigen (psa) for prognostic, recurrence risk assessment of prostate cancers
End-Dated Code/Description
82P--AN / BRAF Mutation Kit
New Code/Description
88P--AN / BRAF Mutation Kit
End-Dated Code/Description
82P--DO / Early growth response gene 1 (egr1) fish probe kit for specimen characterization
New Code/Description
88P--DO / Early growth response gene 1 (egr1) fish probe kit for specimen characterization
End-Dated Code/Description
82P--FG / DNA FISH probe Kit for specimen characterization, human chromosome, hematological disorders
New Code/Description
88P--FG / DNA FISH probe Kit for specimen characterization, human chromosome, hematological disorders
End-Dated Code/Description
82P--FR / System, cystic fibrosis transmembrane conductance regulator gene, mutations & variants panel sequenc
New Code/Description
88P--FR / System, cystic fibrosis transmembrane conductance regulator gene, mutations & variants panel sequenc
End-Dated Code/Description
82P--FS / System, cystic fibrosis transmembrane conductance regulator gene, variant gene sequence detection
New Code/Description
88P--FS / System, cystic fibrosis transmembrane conductance regulator gene, variant gene sequence detection
End-Dated Code/Description
81P--HJ / System, mass spectrometry, multiplex genotyping, hereditary thrombophilia related mutations
New Code/Description
88P--HJ / System, mass spectrometry, multiplex genotyping, hereditary thrombophilia related mutations
End-Dated Code/Description
84G--ZC / Stimulator, Neuromuscular, Implanted
New Code/Description
89G--ZC / Stimulator, Neuromuscular, Implanted
End-Dated Code/Description
87H--SS / Halter, Head, Traction
New Code/Description
89H--SS / Halter, Head, Traction
End-Dated Code/Description
76E--AG / Cephalometer
New Code/Description
90E--AG / Cephalometer
End-Dated Code/Description
76E--AH / Cone, Radiographic, Lead-Lined
New Code/Description
90E--AH / Cone, Radiographic, Lead-Lined
End-Dated Code/Description
76E--AP / Unit, X-Ray, Intraoral
New Code/Description
90E--AP / Unit, X-Ray, Intraoral
End-Dated Code/Description
76E--HB / Collimator, X-Ray
New Code/Description
90E--HB / Collimator, X-Ray
End-Dated Code/Description
76E--HD / Unit, X-Ray, Extraoral With Timer
New Code/Description
90E--HD / Unit, X-Ray, Extraoral With Timer
End-Dated Code/Description
94R--CC / C-Arm Fluoroscopic X-Ray System, Medical Diagnostic X-Ray Equipment
New Code/Description
90R--CC / C-Arm Fluoroscopic X-Ray System, Medical Diagnostic X-Ray Equipment
End-Dated Code/Description
75P--FT / Reagents for molecular diagnostic test systems
New Code/Description
91P--FT / Reagents for molecular diagnostic test systems
End-Dated Code/Description
75Q--BK / Meprobamate test system
New Code/Description
91Q--BK / Meprobamate test system
End-Dated Code/Description
94R--IK / television, non-CRT, non-medical, video display
New Code/Description
95R--IK / television, non-CRT, non-medical, video display
The Food and Drug Administration will be end-dating duplicate codes, effective in 60 days on _____ ___, 2018. The end-dated code and correct code are listed below.
End-Dated Code/Description
79J--CT/Prosthesis, Tracheal
Correct Code/Description
73J--CT/Prosthesis, tracheal, expandable
End-Dated Code/Description
81P--QD/Blood specimen collection convenience kit (excludes HIV)
Correct Code/Description
75P--QD/Blood specimen collection convenience kit (excludes HIV)
End-Dated Code/Description
81P--OD/Temporary, internal use hemostatic
Correct Code/Description
79P--OD/Temporary, internal use hemostatic
End-Dated Code/Description
78F--EB/Accessories, Cleaning, For Endoscope
Correct Code/Description
80F--EB/Accessories, cleaning, for endoscope
End-Dated Code/Description
79L--HF/Warmer, microwave, infusion fluid
Correct Code/Description
80L--HF/Warmer, microwave, infusion fluid
End-Dated Code/Description
74L--LK/Legging, Compression, Non-inflatable
Correct Code/Description
80L--LK/Legging, compression, non-inflatable
End-Dated Code/Description
78N--VE/Washer, Cleaner, automated, endoscope
Correct Code/Description
80N--VE/Washer, cleaner, automated, endoscope
End-Dated Code/Description
78N--ZA/Accessories, germicide, cleaning, for endoscopes
Correct Code/Description
80N--ZA/Accessories, germicide, cleaning, for endoscopes
End-Dated Code/Description
79O--FP/Basic set-up tray
Correct Code/Description
80O--FP/Anesthesia breathing circuit kit (adult & pediatric)
End-Dated Code/Description
81N--ID/Assay, Proliferation, In Vitro, T Lymphocyte
Correct Code/Description
82N--ID/Assay, Interleukin
End-Dated Code/Description
92O--WD/Somatic gene mutation detection system
Correct Code/Description
82O--WD/Somatic gene mutation detection system
End-Dated Code/Description
87H--RW/Dynamometer, nonpowered
Correct Code/Description
84H--RW/Dynamometer, nonpowered
End-Dated Code/Description
87H--ST/Apparatus, traction, non-powered
Correct Code/Description
84H--ST/Apparatus, traction, non-powered
End-Dated Code/Description
87K--QW/Goniometer, nonpowered
Correct Code/Description
84K--QW/Goniometer, nonpowered
End-Dated Code/Description
87K--QX/Goniometer, Ac-Powered
Correct Code/Description
84K--QX/Goniometer, ac-powered
End-Dated Code/Description
87L--BB/Dynamometer, Ac-Powered
Correct Code/Description
84L--BB/Dynamometer, ac-powered
End-Dated Code/Description
87L--YH/Arthrometer
Correct Code/Description
84L--YH/Arthrometer
End-Dated Code/Description
89N--HH/Device, discharge, electrostatic (for pain relief)
Correct Code/Description
84N--HH/Device, Discharge, Electrostatic (for Pain Relief)
End-Dated Code/Description
87N--KI/Goniometer with Electrodes
Correct Code/Description
84N--KI/Goniometer with electrodes
End-Dated Code/Description
86O--PT/INFRARED HEMATOMA DETECTOR
Correct Code/Description
84O--PT/INFRARED HEMATOMA DETECTOR
End-Dated Code/Description
78O--AC/plethysmograph, air displacement for body composition analysis
Correct Code/Description
85O--AC/plethysmograph, air displacement for body composition analysis
End-Dated Code/Description
89H--TM/Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive
Correct Code/Description
87H--TM/Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive
End-Dated Code/Description
92P--ZM/Next generation sequencing based tumor profiling test
Correct Code/Description
88P--ZM/Next generation sequencing based tumor profiling test
End-Dated Code/Description
95R--GC/X-Ray Field Indicator Light (Laser), Positioning Medical Laser Products
Correct Code/Description
90R--GC/X-ray field indicator light (laser)
The Food and Drug administration will be end-dating CDRH product codes, effective in 60 days on November 5, 2018. The end-dated codes are listed below.
End-Dated Code/Description
73K--GA/Cylinder, Gas(Empty)
End-Dated Code/Description
74L--IS/Heparin Coating Chemicals
End-Dated Code/Description
74L--IW/Fibrillator, AC
End-Dated Code/Description
74L--OS/System, ECG Analysis
End-Dated Code/Description
74M--NN/Device, Ablation, Varicose Vein
End-Dated Code/Description
74N--PN/Defibrillator, Automatic, External, for Out-of-Hospital Use
End-Dated Code/Description
74O--VW/Active compression/decompression pump
End-Dated Code/Description
75P--QW/alpha-D-galactosidase A (GLA) newborn screening test system
End-Dated Code/Description
76E--CF/Sterilizer, Dry Heat, Endodontic
End-Dated Code/Description
77E--NL/Nasograph
End-Dated Code/Description
77E--TL/Nasal Flowmeter
End-Dated Code/Description
77J--CS/Prosthesis, Maxilla
End-Dated Code/Description
77K--HK/Polymer, Ent Natural-Collagen Material
End-Dated Code/Description
77M--GF/Collagen, Injectable For Vocal Cord Augmentation
End-Dated Code/Description
78F--TK/Pancreatoscope, Biliary
End-Dated Code/Description
78K--OG/Endoscope And/Or Accessories
End-Dated Code/Description
78K--PG/Magnet, Continent Colostomy
End-Dated Code/Description
78L--NN/Device, Anastomosis for Gastro-Urology Use
End-Dated Code/Description
78L--TH/Graft, Vascular Access
End-Dated Code/Description
78N--NF/Set, Dialysis, Single needle (co-axial flow), Reprocessed
End-Dated Code/Description
78Q--AM/Apheresis for focal glomerulosclerosis for adult and pediatric patients
End-Dated Code/Description
79E--SY/Prosthesis, Otoplasty
End-Dated Code/Description
79K--DB/Instrument, Disposal, Surgical (Sharps)
End-Dated Code/Description
80L--DQ/Device, General Medical
End-Dated Code/Description
80N--PC/Glove, Patient Examination, Powder Free
End-Dated Code/Description
83P--RD/Biothreat microbial agents multiplex nucleic acid detection system
End-Dated Code/Description
83P--RH/Positive blood culture identification and AST kit
End-Dated Code/Description
84M--QD/Electrode, Cone, Implantable
End-Dated Code/Description
85M--MN/Ductoscope, Breast
End-Dated Code/Description
85N--HR/Material, Implant, Uterine, for Adhesiogenic Effect
End-Dated Code/Description
85N--MO/Needle, Aspiration, Oocyte, Reprocessed
End-Dated Code/Description
86O--RS/Magnetotherapy device for pain relief
End-Dated Code/Description
87M--CJ/Pump, Vacuum, Electric, Suction-Type Electrode
End-Dated Code/Description
89I--PQ/Control, Hand Driving, Automobile, Mechanical
End-Dated Code/Description
89P--GA/Electroporation, transdermal delivery
End-Dated Code/Description
91N--ED/Kit, Test, Malaria
End-Dated Code/Description
95R--FH/UV Curing, Material Processing Laser Products
End-Dated Code/Description
95R--GR/Air Purifier, Ultraviolet Commercial/Consumer
End-Dated Code/Description
95R--ZN/General Industrial Use Material Processing Laser Products
End-Dated Code/Description
95R--ZP/Home/Office Machine Incorporating, Utility/Peripheral Laser
End-Dated Code/Description
95R--ZS/Positioning Medical Laser Product
The Food and Drug administration has created new CDRH product codes, effective immediately. The product codes are listed below.
New Code/Description
73Q—AV/ High flow/high velocity humidified oxygen delivery device
New Code/Description
73Q—BY/ Positive airway pressure system
New Code/Description
74N—PU/ Prosthesis, Mitral Valve, Percutaneously Delivered
New Code/Description
74Q—BI/ Acute coronary syndrome event detector
New Code/Description
83P—RA/ Variola virus nucleic acid-based detection assay
New Code/Description
91P—RF/ Docetaxel / Paclitaxel assay
Please send any questions or concerns to the email address for the Product Code Builder Feedback PCBFeedback@fda.hhs.gov. For questions or concerns regarding ACE, contact ACE_Support@fda.hhs.gov.
Note that supplemental information to this message is available in the form of one or more file downloads.
Please follow the link in this email message to the CSMS web site to access this information.
The Food and Drug Administration has created new product codes, which will be available in 60 days on November 5, 2018. The Food and Drug Administration is also end-dating product codes, effective in 60 days November 5, 2018. The new and end-dated codes are described below.
End-Dated Code/Description
74D--WM/Apparatus, Suction, Patient Care
New Code/Description
73D--WM / Apparatus, Suction, Patient Care
End-Dated Code/Description
84G--ZE / Stimulator, Diaphragmatic/Phrenic Nerve, Implanted
New Code/Description
73G--ZE / Stimulator, Diaphragmatic/Phrenic Nerve, Implanted
End-Dated Code/Description
74P--GJ / Oximeter, wellness
New Code/Description
73P--GJ / Oximeter, wellness
End-Dated Code/Description
82J--MG / Radioimmunoassay (Two-Site Solid Phase), Ferritin
New Code/Description
75J--MG / Radioimmunoassay (Two-Site Solid Phase), Ferritin
End-Dated Code/Description
91P--HV / Continuous glucose monitor retrospective data analysis software
New Code/Description
75P--HV / Continuous glucose monitor retrospective data analysis software
End-Dated Code/Description
77O--HP / Expiratory resistance valve, intranasal, for obstructive sleep apnea
New Code/Description
76O--HP / Expiratory resistance valve, intranasal, for obstructive sleep apnea
End-Dated Code/Description
84G--ZD / Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation
New Code/Description
78G--ZD / Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation
End-Dated Code/Description
85H--IR / Perineometer
New Code/Description
78H--IR / Perineometer
End-Dated Code/Description
74M--NW / Analyzer, Body Composition
New Code/Description
78M--NW / Analyzer, Body Composition
End-Dated Code/Description
85O--TN / Mesh, surgical, gynecologic, for stress urinary incontinence, female
New Code/Description
78O--TN / Mesh, surgical, gynecologic, for stress urinary incontinence, female
End-Dated Code/Description
80O--ZW / Ingestible event marker
New Code/Description
78O--ZW / Ingestible event marker
End-Dated Code/Description
85P--AG / Mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, female, multi-incisi
New Code/Description
78P--AG / Mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, female, multi-incisi
End-Dated Code/Description
85P--AH / Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, single-incision
New Code/Description
78P--AH / Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, single-incision
End-Dated Code/Description
74P--UH / Analyzer, body composition, exempt
New Code/Description
78P--UH / Analyzer, body composition, exempt
End-Dated Code/Description
85P--WJ / Instrumentation, surgical mesh, urogynecologic, stress urinary incontinence
New Code/Description
78P--WJ / Instrumentation, surgical mesh, urogynecologic, stress urinary incontinence
End-Dated Code/Description
78E--XM / Truss, Umbilical
New Code/Description
79E--XM / Truss, Umbilical
End-Dated Code/Description
78E--YN / Tray, Irrigation, Sterile
New Code/Description
79E--YN / Tray, Irrigation, Sterile
End-Dated Code/Description
78F--BQ / Trocar, Gastro-Urology
New Code/Description
79F--BQ / Trocar, Gastro-Urology
End-Dated Code/Description
78F--DP / Apparatus, Pneumoperitoneum, Automatic
New Code/Description
79F--DP / Apparatus, Pneumoperitoneum, Automatic
End-Dated Code/Description
78F--SH / Tray, surgical, needle
New Code/Description
79F--SH / Tray, surgical, needle
End-Dated Code/Description
78G--CG / Peritoneoscope
New Code/Description
79G--CG / Peritoneoscope
End-Dated Code/Description
78G--CH / Mediastinoscope
New Code/Description
79G--CH / Mediastinoscope
End-Dated Code/Description
78G--CI / Laryngoscope
New Code/Description
79G--CI / Laryngoscope
End-Dated Code/Description
74M--VR / Device, Anastomotic, Microvascular
New Code/Description
79M--VR / Device, Anastomotic, Microvascular
End-Dated Code/Description
89N--ZF / Massager, cosmetic, static electricity-emitting
New Code/Description
79N--ZF / Massager, cosmetic, static electricity-emitting
End-Dated Code/Description
84N--ZY / Light, lymphadema reduction, low energy
New Code/Description
79N--ZY / Light, lymphadema reduction, low energy
End-Dated Code/Description
84O--NA / Stereotaxic instrument
New Code/Description
79O--NA / Stereotaxic instrument
End-Dated Code/Description
80P--BZ / Surgical sponge visual scale
New Code/Description
79P--BZ / Surgical sponge visual scale
End-Dated Code/Description
78P--HU / Intra-abdominal pressure monitoring device
New Code/Description
79P--HU / Intra-abdominal pressure monitoring device
End-Dated Code/Description
73C--AH / Filter, Bacterial, Breathing-Circuit
New Code/Description
80C--AH / Filter, Bacterial, Breathing-Circuit
End-Dated Code/Description
74D--QF / Actuator, Syringe, Injector Type
New Code/Description
80D--QF / Actuator, Syringe, Injector Type
End-Dated Code/Description
74D--QI / Pump, Withdrawal/Infusion
New Code/Description
80D--QI / Pump, Withdrawal/Infusion
End-Dated Code/Description
79E--YX / Drape, Pure Latex Sheet, With Self-Retaining Finger Cot
New Code/Description80E--YX / Drape, Pure Latex Sheet, With Self-Retaining Finger Cot
End-Dated Code/Description
79E--YY / Drape, Urological, Disposable
New Code/Description
80E--YY / Drape, Urological, Disposable
End-Dated Code/Description
79F--IJ / System, Dialysate Delivery, Recirculating, Single Pass
New Code/Description
80F--IJ / System, Dialysate Delivery, Recirculating, Single Pass
End-Dated Code/Description
79F--RT / Unit, Isolation, Surgical
New Code/Description
80F--RT / Unit, Isolation, Surgical
End-Dated Code/Description
79F--XO / Suit, Surgical
New Code/Description
80F--XO / Suit, Surgical
End-Dated Code/Description
79F--XP / Cover, Shoe, Operating-Room
New Code/Description
80F--XP / Cover, Shoe, Operating-Room
End-Dated Code/Description
79F--XX / Mask, Surgical
New Code/Description
80F--XX / Mask, Surgical
End-Dated Code/Description
79F--XY / Hood, Surgical
New Code/Description
80F--XY / Hood, Surgical
End-Dated Code/Description
79F--XZ / Helmet, Surgical
New Code/Description
80F--XZ / Helmet, Surgical
End-Dated Code/Description
79F--YA / Gown, Surgical
New Code/Description
80F--YA / Gown, Surgical
End-Dated Code/Description
79F--YB / Gown, Patient
New Code/Description
80F--YB / Gown, Patient
End-Dated Code/Description
79F--YC / Gown, Isolation, Surgical
New Code/Description
80F--YC / Gown, Isolation, Surgical
End-Dated Code/Description
79F--YD / Apparatus, Exhaust, Surgical
New Code/Description
80F--YD / Apparatus, Exhaust, Surgical
End-Dated Code/Description
79F--YH / Splint, Extremity, Noninflatable, External
New Code/Description
80F--YH / Splint, Extremity, Noninflatable, External
End-Dated Code/Description
79H--MT / Drape, Patient, Ophthalmic
New Code/Description
80H--MT / Drape, Patient, Ophthalmic
End-Dated Code/Description
79H--MW / Drape, Microscope, Ophthalmic
New Code/Description
80H--MW / Drape, Microscope, Ophthalmic
End-Dated Code/Description
89I--QG / Adaptor, Holder, Syringe
New Code/Description
80--QG / Adaptor, Holder, Syringe
End-Dated Code/Description
79K--GO / Surgeon's Gloves
New Code/Description
80K--GO / Surgeon's Gloves
End-Dated Code/Description
79K--GQ / Cream, Gloving, Surgeon's
New Code/Description
80K--GQ / Cream, Gloving, Surgeon's
End-Dated Code/Description
79K--GT / Drape, Adhesive, Aerosol
New Code/Description
80K--GT / Drape, Adhesive, Aerosol
End-Dated Code/Description
79K--KX / Drape, Surgical
New Code/Description
80K--KX / Drape, Surgical
End-Dated Code/Description
79K--KY / Material, Polytetrafluoroethylene Vitreous Carbon for Maxillofacial Reconstruction
New Code/Description
80K--KY / Material, Polytetrafluoroethylene Vitreous Carbon for Maxillofacial Reconstruction
End-Dated Code/Description
79L--YU / Accessory, Surgical Apparel
New Code/Description
80L--YU / Accessory, Surgical Apparel
End-Dated Code/Description
79M--AC / Decontamination kit
New Code/Description
80M--AC / Decontamination kit
End-Dated Code/Description
79N--DC / Calculator, Drug Dose
New Code/Description
80N--DC / Calculator, Drug Dose
End-Dated Code/Description
89N--XB / Dispenser, solid medication
New Code/Description
80N--XB / Dispenser, solid medication
End-Dated Code/Description
74O--FM / Phlebotomy blood collection kit
New Code/Description
80O--FM / Phlebotomy blood collection kit
End-Dated Code/Description
89O--JL / insulin vial protector/holder
New Code/Description
80O--JL / insulin vial protector/holder
End-Dated Code/Description
79O--PA / Powder-free synthetic/non-latex surgeon's gloves
New Code/Description
80O--PA / Powder-free synthetic/non-latex surgeon's gloves
End-Dated Code/Description
79O--VR / Kit, first aid, talking
New Code/Description
80O--VR / Kit, first aid, talking
End-Dated Code/Description
82D--BT / Factor Xiii A, S, Antigen, Antiserum, Control
New Code/Description
81D--BT / Factor Xiii A, S, Antigen, Antiserum, Control
End-Dated Code/Description
82D--DE / Carbonic Anhydrase C, Antigen, Antiserum, Control
New Code/Description
81D--DE / Carbonic Anhydrase C, Antigen, Antiserum, Control
End-Dated Code/Description
82D--DF / Prothrombin, Antigen, Antiserum, Control
New Code/Description
81D--DF / Prothrombin, Antigen, Antiserum, Control
End-Dated Code/Description
82D--DH / Carbonic Anhydrase B, Antigen, Antiserum, Control
New Code/Description
81D--DH / Carbonic Anhydrase B, Antigen, Antiserum, Control
End-Dated Code/Description
82D--DX / Plasminogen, Antigen, Antiserum, Control
New Code/Description
81D--DX / Plasminogen, Antigen, Antiserum, Control
End-Dated Code/Description
82D--GB / Seminal Fluid, Antigen, Antiserum, Control
New Code/Description
81D--GB / Seminal Fluid, Antigen, Antiserum, Control
End-Dated Code/Description
82D--GQ / Whole Blood Plasma, Antigen, Antiserum, Control
New Code/Description
81D--GQ / Whole Blood Plasma, Antigen, Antiserum, Control
End-Dated Code/Description
82D--GR / Whole Human Serum, Antigen, Antiserum, Control
New Code/Description
81D--GR / Whole Human Serum, Antigen, Antiserum, Control
End-Dated Code/Description
88G--JH / Stain, Reticulocyte
New Code/Description
81G--JH / Stain, Reticulocyte
End-Dated Code/Description
88G--JJ / Stains, Heinz Body
New Code/Description
81G--JJ / Stains, Heinz Body
End-Dated Code/Description
88G--JL / Romanowsky Stains
New Code/Description
81G--JL / Romanowsky Stains
End-Dated Code/Description
88I--AZ / Heparin
New Code/Description
81I--AZ / Heparin
End-Dated Code/Description
88I--FO / Solution, Newcomer's
New Code/Description
81I--FO / Solution, Newcomer's
End-Dated Code/Description
88I--FS / Solution, Helly
New Code/Description
81I--FS / Solution, Helly
End-Dated Code/Description
88I--GK / Solution, Clarke's
New Code/Description
81I--GK / Solution, Clarke's
End-Dated Code/Description
88I--JZ / Oil, Clearing
New Code/Description
81I--JZ / Oil, Clearing
End-Dated Code/Description
82K--TK / Reagent, Immunoassay, Carbonic Anhydrase B and C
New Code/Description
81K--TK / Reagent, Immunoassay, Carbonic Anhydrase B and C
End-Dated Code/Description
88L--KM / Counter, Urine Particle
New Code/Description
81L--KM / Counter, Urine Particle
End-Dated Code/Description
85M--NA / Device, Semen Analysis
New Code/Description
81M--NA / Device, Semen Analysis
End-Dated Code/Description
82O--VQ / Chronic lymphocytic leukemia fish probe kit
New Code/Description
81O--VQ / Chronic lymphocytic leukemia fish probe kit
End-Dated Code/Description
82P--CZ / Investigational use only - Immunology
New Code/Description
81P--CZ / Investigational use only - Immunology
End-Dated Code/Description
73P--HY / Sparse sample PK profile and dosing software
New Code/Description
81P--HY / Sparse sample PK profile and dosing software
End-Dated Code/Description
88I--BB / Phytohemaglutinin M
New Code/Description
82I--BB / Phytohemaglutinin M
End-Dated Code/Description
88K--EF / Paraformaldehyde
New Code/Description
82K--EF / Paraformaldehyde
End-Dated Code/Description
81K--EX / Sorter, Cell
New Code/Description
82K--EX / Sorter, Cell
End-Dated Code/Description
81L--IZ / Assay, T Lymphocyte Surface Marker
New Code/Description
82L--IZ / Assay, T Lymphocyte Surface Marker
End-Dated Code/Description
81L--JD / Assay, B Lymphocyte Marker
New Code/Description
82L--JD / Assay, B Lymphocyte Marker
End-Dated Code/Description
81M--AN / Assay, Interleukin
New Code/Description
82M--AN / Assay, Interleukin
End-Dated Code/Description
81P--DX / Flow cytometry calibrator
New Code/Description
82P--DX / Flow cytometry calibrator
End-Dated Code/Description
83P--JI / Severe combined immunodeficiency disorder (SCID) Newborn Screening Test System
New Code/Description
82P--JI / Severe combined immunodeficiency disorder (SCID) Newborn Screening Test System
End-Dated Code/Description
82O--UY / TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM
New Code/Description
83O--UY / TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM
End-Dated Code/Description
73B--WK / Stimulator, Electro-Acupuncture
New Code/Description
84B--WK / Stimulator, Electro-Acupuncture
End-Dated Code/Description
89I--KN / Electromyograph, Diagnostic
New Code/Description
84I--KN / Electromyograph, Diagnostic
End-Dated Code/Description
89I--KT / Electrode, Needle, Diagnostic Electromyograph
New Code/Description
84I--KT / Electrode, Needle, Diagnostic Electromyograph
End-Dated Code/Description
89M--LQ / Inhibitor, Peridural Fibrosis (Adhesion Barrier)
New Code/Description
84M--LQ / Inhibitor, Peridural Fibrosis (Adhesion Barrier)
End-Dated Code/Description
87O--AN / orthosis, cranial, laser scan
New Code/Description
84O--AN / orthosis, cranial, laser scan
End-Dated Code/Description
77O--RR / Neurological stereotaxic instrument, real-time intraoperative mri
New Code/Description
84O--RR / Neurological stereotaxic instrument, real-time intraoperative mri
End-Dated Code/Description
89O--TX / Foot wrap for treating restless leg syndrome symptoms
New Code/Description
84O--TX / Foot wrap for treating restless leg syndrome symptoms
End-Dated Code/Description
89O--VP / Vibratory counter-stimulation
New Code/Description
84O--VP / Vibratory counter-stimulation
End-Dated Code/Description
89O--ZJ / Inhibitor, postoperative fibrosis (adhesion barrier)
New Code/Description
84O--ZJ / Inhibitor, postoperative fibrosis (adhesion barrier)
End-Dated Code/Description
89P--CQ / Inhibitor, postoperative fibrosis (spine adhesion barrier)
New Code/Description
84P--CQ / Inhibitor, postoperative fibrosis (spine adhesion barrier)
End-Dated Code/Description
89P--HL / Powered Exoskeleton
New Code/Description
84P--HL / Powered Exoskeleton
End-Dated Code/Description
78M--CI / Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite
New Code/Description
85M--CI / Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite
End-Dated Code/Description
90N--RZ / Ablation System, High intensity focused Ultrasound (HIFU), MR-Guided
New Code/Description
85N--RZ / Ablation System, High intensity focused Ultrasound (HIFU), MR-Guided
End-Dated Code/Description
74O--SV / Insfufflator, endoscopic vessel harvesting
New Code/Description
85O--SV / Insfufflator, endoscopic vessel harvesting
End-Dated Code/Description
90P--AS / RF/Microwave hyperthermia system, cancer treatment
New Code/Description
85P--AS / RF/Microwave hyperthermia system, cancer treatment
End-Dated Code/Description
78P--SI / Perineal irrigation kit
New Code/Description
85P--SI / Perineal irrigation kit
End-Dated Code/Description
79J--DJ / Prosthesis, Hip, Acetabular Mesh
New Code/Description
87J--DJ / Prosthesis, Hip, Acetabular Mesh
End-Dated Code/Description
79J--DK / Prosthesis, Hip, Cement Restrictor
New Code/Description
87J--DK / Prosthesis, Hip, Cement Restrictor
End-Dated Code/Description
89M--BP / Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
New Code/Description
87M--BP / Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
End-Dated Code/Description
89M--BS / Filler, Bone Void, Non-Osteoinduction
New Code/Description
87M--BS / Filler, Bone Void, Non-Osteoinduction
End-Dated Code/Description
89M--PW / Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
New Code/Description
87M--PW / Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
End-Dated Code/Description
84O--JP / orthopedic computer controlled surgical system
New Code/Description
87O--JP / orthopedic computer controlled surgical system
End-Dated Code/Description
84O--NN / intraoperative orthopedic joint assessment aid
New Code/Description
87O--NN / intraoperative orthopedic joint assessment aid
End-Dated Code/Description
82D--AA / Igg, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--AA / Igg, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--EP / Lambda, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--EP / Lambda, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--EY / Igm, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--EY / Igm, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--FD / Kappa, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--FD / Kappa, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--GH / Igd, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--GH / Igd, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--GO / Ige, Peroxidase, Antigen, Antiserum, Control
New Code/Description
88D--GO / Ige, Peroxidase, Antigen, Antiserum, Control
End-Dated Code/Description
82D--HF / D/Km-1, Antigen, Antiserum, Control
New Code/Description
88D--HF / D/Km-1, Antigen, Antiserum, Control
End-Dated Code/Description
81G--IA / Test, Leukocyte Peroxidase
New Code/Description
88G--IA / Test, Leukocyte Peroxidase
End-Dated Code/Description
82L--YE / Cytokeratins
New Code/Description
88L--YE / Cytokeratins
End-Dated Code/Description
81M--AO / DNA-Probe, Human Chromosome
New Code/Description
88M--AO / DNA-Probe, Human Chromosome
End-Dated Code/Description
81M--TI / Kit, Cell Screening, Fetal
New Code/Description
88M--TI / Kit, Cell Screening, Fetal
End-Dated Code/Description
82M--VD / System, Test, HER-2/NEU, Nucleic Acid or Serum
New Code/Description
88M--VD / System, Test, HER-2/NEU, Nucleic Acid or Serum
End-Dated Code/Description
81N--PQ / Test, Factor V Leiden Mutations, Genomic DNA PCR
New Code/Description
88N--PQ / Test, Factor V Leiden Mutations, Genomic DNA PCR
End-Dated Code/Description
81N--PR / Test, Factor II G20210A Mutations, Genomic DNA PCR
New Code/Description
88N--PR / Test, Factor II G20210A Mutations, Genomic DNA PCR
End-Dated Code/Description
82N--SD / Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for rec
New Code/Description
88N--SD / Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for rec
End-Dated Code/Description
82N--TH / System, Automated scanning microscope and image analysis for fluorescience in Situ Hybridization (Fi
New Code/Description
88N--TH / System, Automated scanning microscope and image analysis for fluorescience in Situ Hybridization (Fi
End-Dated Code/Description
82N--TW / System, Blood Collection, RNA Stabilization, RNA Purification, RT-PCR Molecular Diagnostic Test
New Code/Description
88N--TW / System, Blood Collection, RNA Stabilization, RNA Purification, RT-PCR Molecular Diagnostic Test
End-Dated Code/Description
82N--UA / System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detention
New Code/Description
88N--UA / System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detention
End-Dated Code/Description
82N--XG / Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
New Code/Description
88N--XG / Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
End-Dated Code/Description
82N--YI / Classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer
New Code/Description
88N--YI / Classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer
End-Dated Code/Description
82O--QS / Laboratory developed test
New Code/Description
88O--QS / Laboratory developed test
End-Dated Code/Description
82O--WE / Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
New Code/Description
88O--WE / Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
End-Dated Code/Description
82O--WM / Prostate-specific antigen (psa) for prognostic, recurrence risk assessment of prostate cancers
New Code/Description
88O--WM / Prostate-specific antigen (psa) for prognostic, recurrence risk assessment of prostate cancers
End-Dated Code/Description
82P--AN / BRAF Mutation Kit
New Code/Description
88P--AN / BRAF Mutation Kit
End-Dated Code/Description
82P--DO / Early growth response gene 1 (egr1) fish probe kit for specimen characterization
New Code/Description
88P--DO / Early growth response gene 1 (egr1) fish probe kit for specimen characterization
End-Dated Code/Description
82P--FG / DNA FISH probe Kit for specimen characterization, human chromosome, hematological disorders
New Code/Description
88P--FG / DNA FISH probe Kit for specimen characterization, human chromosome, hematological disorders
End-Dated Code/Description
82P--FR / System, cystic fibrosis transmembrane conductance regulator gene, mutations & variants panel sequenc
New Code/Description
88P--FR / System, cystic fibrosis transmembrane conductance regulator gene, mutations & variants panel sequenc
End-Dated Code/Description
82P--FS / System, cystic fibrosis transmembrane conductance regulator gene, variant gene sequence detection
New Code/Description
88P--FS / System, cystic fibrosis transmembrane conductance regulator gene, variant gene sequence detection
End-Dated Code/Description
81P--HJ / System, mass spectrometry, multiplex genotyping, hereditary thrombophilia related mutations
New Code/Description
88P--HJ / System, mass spectrometry, multiplex genotyping, hereditary thrombophilia related mutations
End-Dated Code/Description
84G--ZC / Stimulator, Neuromuscular, Implanted
New Code/Description
89G--ZC / Stimulator, Neuromuscular, Implanted
End-Dated Code/Description
87H--SS / Halter, Head, Traction
New Code/Description
89H--SS / Halter, Head, Traction
End-Dated Code/Description
76E--AG / Cephalometer
New Code/Description
90E--AG / Cephalometer
End-Dated Code/Description
76E--AH / Cone, Radiographic, Lead-Lined
New Code/Description
90E--AH / Cone, Radiographic, Lead-Lined
End-Dated Code/Description
76E--AP / Unit, X-Ray, Intraoral
New Code/Description
90E--AP / Unit, X-Ray, Intraoral
End-Dated Code/Description
76E--HB / Collimator, X-Ray
New Code/Description
90E--HB / Collimator, X-Ray
End-Dated Code/Description
76E--HD / Unit, X-Ray, Extraoral With Timer
New Code/Description
90E--HD / Unit, X-Ray, Extraoral With Timer
End-Dated Code/Description
94R--CC / C-Arm Fluoroscopic X-Ray System, Medical Diagnostic X-Ray Equipment
New Code/Description
90R--CC / C-Arm Fluoroscopic X-Ray System, Medical Diagnostic X-Ray Equipment
End-Dated Code/Description
75P--FT / Reagents for molecular diagnostic test systems
New Code/Description
91P--FT / Reagents for molecular diagnostic test systems
End-Dated Code/Description
75Q--BK / Meprobamate test system
New Code/Description
91Q--BK / Meprobamate test system
End-Dated Code/Description
94R--IK / television, non-CRT, non-medical, video display
New Code/Description
95R--IK / television, non-CRT, non-medical, video display
The Food and Drug Administration will be end-dating duplicate codes, effective in 60 days on _____ ___, 2018. The end-dated code and correct code are listed below.
End-Dated Code/Description
79J--CT/Prosthesis, Tracheal
Correct Code/Description
73J--CT/Prosthesis, tracheal, expandable
End-Dated Code/Description
81P--QD/Blood specimen collection convenience kit (excludes HIV)
Correct Code/Description
75P--QD/Blood specimen collection convenience kit (excludes HIV)
End-Dated Code/Description
81P--OD/Temporary, internal use hemostatic
Correct Code/Description
79P--OD/Temporary, internal use hemostatic
End-Dated Code/Description
78F--EB/Accessories, Cleaning, For Endoscope
Correct Code/Description
80F--EB/Accessories, cleaning, for endoscope
End-Dated Code/Description
79L--HF/Warmer, microwave, infusion fluid
Correct Code/Description
80L--HF/Warmer, microwave, infusion fluid
End-Dated Code/Description
74L--LK/Legging, Compression, Non-inflatable
Correct Code/Description
80L--LK/Legging, compression, non-inflatable
End-Dated Code/Description
78N--VE/Washer, Cleaner, automated, endoscope
Correct Code/Description
80N--VE/Washer, cleaner, automated, endoscope
End-Dated Code/Description
78N--ZA/Accessories, germicide, cleaning, for endoscopes
Correct Code/Description
80N--ZA/Accessories, germicide, cleaning, for endoscopes
End-Dated Code/Description
79O--FP/Basic set-up tray
Correct Code/Description
80O--FP/Anesthesia breathing circuit kit (adult & pediatric)
End-Dated Code/Description
81N--ID/Assay, Proliferation, In Vitro, T Lymphocyte
Correct Code/Description
82N--ID/Assay, Interleukin
End-Dated Code/Description
92O--WD/Somatic gene mutation detection system
Correct Code/Description
82O--WD/Somatic gene mutation detection system
End-Dated Code/Description
87H--RW/Dynamometer, nonpowered
Correct Code/Description
84H--RW/Dynamometer, nonpowered
End-Dated Code/Description
87H--ST/Apparatus, traction, non-powered
Correct Code/Description
84H--ST/Apparatus, traction, non-powered
End-Dated Code/Description
87K--QW/Goniometer, nonpowered
Correct Code/Description
84K--QW/Goniometer, nonpowered
End-Dated Code/Description
87K--QX/Goniometer, Ac-Powered
Correct Code/Description
84K--QX/Goniometer, ac-powered
End-Dated Code/Description
87L--BB/Dynamometer, Ac-Powered
Correct Code/Description
84L--BB/Dynamometer, ac-powered
End-Dated Code/Description
87L--YH/Arthrometer
Correct Code/Description
84L--YH/Arthrometer
End-Dated Code/Description
89N--HH/Device, discharge, electrostatic (for pain relief)
Correct Code/Description
84N--HH/Device, Discharge, Electrostatic (for Pain Relief)
End-Dated Code/Description
87N--KI/Goniometer with Electrodes
Correct Code/Description
84N--KI/Goniometer with electrodes
End-Dated Code/Description
86O--PT/INFRARED HEMATOMA DETECTOR
Correct Code/Description
84O--PT/INFRARED HEMATOMA DETECTOR
End-Dated Code/Description
78O--AC/plethysmograph, air displacement for body composition analysis
Correct Code/Description
85O--AC/plethysmograph, air displacement for body composition analysis
End-Dated Code/Description
89H--TM/Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive
Correct Code/Description
87H--TM/Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive
End-Dated Code/Description
92P--ZM/Next generation sequencing based tumor profiling test
Correct Code/Description
88P--ZM/Next generation sequencing based tumor profiling test
End-Dated Code/Description
95R--GC/X-Ray Field Indicator Light (Laser), Positioning Medical Laser Products
Correct Code/Description
90R--GC/X-ray field indicator light (laser)
The Food and Drug administration will be end-dating CDRH product codes, effective in 60 days on November 5, 2018. The end-dated codes are listed below.
End-Dated Code/Description
73K--GA/Cylinder, Gas(Empty)
End-Dated Code/Description
74L--IS/Heparin Coating Chemicals
End-Dated Code/Description
74L--IW/Fibrillator, AC
End-Dated Code/Description
74L--OS/System, ECG Analysis
End-Dated Code/Description
74M--NN/Device, Ablation, Varicose Vein
End-Dated Code/Description
74N--PN/Defibrillator, Automatic, External, for Out-of-Hospital Use
End-Dated Code/Description
74O--VW/Active compression/decompression pump
End-Dated Code/Description
75P--QW/alpha-D-galactosidase A (GLA) newborn screening test system
End-Dated Code/Description
76E--CF/Sterilizer, Dry Heat, Endodontic
End-Dated Code/Description
77E--NL/Nasograph
End-Dated Code/Description
77E--TL/Nasal Flowmeter
End-Dated Code/Description
77J--CS/Prosthesis, Maxilla
End-Dated Code/Description
77K--HK/Polymer, Ent Natural-Collagen Material
End-Dated Code/Description
77M--GF/Collagen, Injectable For Vocal Cord Augmentation
End-Dated Code/Description
78F--TK/Pancreatoscope, Biliary
End-Dated Code/Description
78K--OG/Endoscope And/Or Accessories
End-Dated Code/Description
78K--PG/Magnet, Continent Colostomy
End-Dated Code/Description
78L--NN/Device, Anastomosis for Gastro-Urology Use
End-Dated Code/Description
78L--TH/Graft, Vascular Access
End-Dated Code/Description
78N--NF/Set, Dialysis, Single needle (co-axial flow), Reprocessed
End-Dated Code/Description
78Q--AM/Apheresis for focal glomerulosclerosis for adult and pediatric patients
End-Dated Code/Description
79E--SY/Prosthesis, Otoplasty
End-Dated Code/Description
79K--DB/Instrument, Disposal, Surgical (Sharps)
End-Dated Code/Description
80L--DQ/Device, General Medical
End-Dated Code/Description
80N--PC/Glove, Patient Examination, Powder Free
End-Dated Code/Description
83P--RD/Biothreat microbial agents multiplex nucleic acid detection system
End-Dated Code/Description
83P--RH/Positive blood culture identification and AST kit
End-Dated Code/Description
84M--QD/Electrode, Cone, Implantable
End-Dated Code/Description
85M--MN/Ductoscope, Breast
End-Dated Code/Description
85N--HR/Material, Implant, Uterine, for Adhesiogenic Effect
End-Dated Code/Description
85N--MO/Needle, Aspiration, Oocyte, Reprocessed
End-Dated Code/Description
86O--RS/Magnetotherapy device for pain relief
End-Dated Code/Description
87M--CJ/Pump, Vacuum, Electric, Suction-Type Electrode
End-Dated Code/Description
89I--PQ/Control, Hand Driving, Automobile, Mechanical
End-Dated Code/Description
89P--GA/Electroporation, transdermal delivery
End-Dated Code/Description
91N--ED/Kit, Test, Malaria
End-Dated Code/Description
95R--FH/UV Curing, Material Processing Laser Products
End-Dated Code/Description
95R--GR/Air Purifier, Ultraviolet Commercial/Consumer
End-Dated Code/Description
95R--ZN/General Industrial Use Material Processing Laser Products
End-Dated Code/Description
95R--ZP/Home/Office Machine Incorporating, Utility/Peripheral Laser
End-Dated Code/Description
95R--ZS/Positioning Medical Laser Product
The Food and Drug administration has created new CDRH product codes, effective immediately. The product codes are listed below.
New Code/Description
73Q—AV/ High flow/high velocity humidified oxygen delivery device
New Code/Description
73Q—BY/ Positive airway pressure system
New Code/Description
74N—PU/ Prosthesis, Mitral Valve, Percutaneously Delivered
New Code/Description
74Q—BI/ Acute coronary syndrome event detector
New Code/Description
83P—RA/ Variola virus nucleic acid-based detection assay
New Code/Description
91P—RF/ Docetaxel / Paclitaxel assay
Please send any questions or concerns to the email address for the Product Code Builder Feedback PCBFeedback@fda.hhs.gov. For questions or concerns regarding ACE, contact ACE_Support@fda.hhs.gov.
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