CSMS# 19-000132 - FDA New and End-Dated CVM Class Codes and Product Codes
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03/15/2019 12:11 PM EDT
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The Food and Drug Administration will be adding and ending CVM Class Codes and Product Codes under Industry Code 68, described below and in attached list.
The Class Code X will be end-dated in 30 days and expiring on April 15, 2019.
Class Code/Description
X/Device/Diag Prod For Animal
The Product Codes below will be end-dated in 30 days and expiring on April 15, 2019.
Product Code/Description
68X--01/Cattle Device/Diag Prod For Animal
68X--02/Horses Device/Diag Prod For Animal
68X--03/Poultry Device/Diag Prod For Animal
68X--04/Sheep Device/Diag Prod For Animal
68X--05/Swine Device/Diag Prod For Animal
68X--10/Small Animal Device/Diag Prod For Animal
68X--20/Device/Diag Prod For Animal Used More Than 1 Species
68X--99/Other Animal, N.E.C. Device/Diag Prod For Animal
The new Class Code S will be available in 30 days, on April 15, 2019
Class Code/Description
S/Diagnostics (in vivo, in vitro and NEC)-Nonhuman
The new Product Codes below will be available in 30 days, on April 15, 2019
Product Code/Description
68S--01/In Vitro Test Kits, Individual (Nonhuman)
68S--02/In Vitro Test Kits, Multi-patient (Nonhuman)
68S--03/In Vivo Test Kits, Individual (Nonhuman)
68S--04/In Vivo Test Kits, Multi-patient (Nonhuman)
68S--05/Replacement Chemicals for Serum Analyzers (Nonhuman)
68S--06/Replacement Chemicals for Hematology Analyzers (Nonhuman)
68S--07/Parasite Egg Flotation Solution (Nonhuman)
68S--08/Parasite Diagnostic Tools, Other (Nonhuman)
68S--99/Animal Diagnostics, NEC
The new Class Codes below are available immediately.
Class Code/Description
L/Disposables/single use devices-Nonhuman
M/Large hospital/clinic equipment-Nonhuman
N/Small hospital/clinic equipment-Nonhuman
O/Anesthesia-Nonhuman
P/Orthopedic-Nonhuman
Q/Ophthalmic-Nonhuman
R/Dental-Nonhuman
Z/Animal Medical Devices, NEC
The new Product Codes below are available immediately.
Product Code/Description
68L--01/Biopsy instruments, single use (Nonhuman)
68L--02/Blood tubes, plain (Nonhuman)
68L--03/Blood tubes with additive (Nonhuman)
68L--04/Blood collection bags, tubing and accessories (Nonhuman)
68L--05/Catheters, Intravenous (Nonhuman)
68L--06/Catheters, Urinary (Nonhuman)
68L--07/Catheters, Other (Nonhuman)
68L--08/Fluid administration tubing, sets, and related accessories (Nonhuman)
68L--09/Needles for injection (Nonhuman)
68L--10/Needles for suture (Nonhuman)
68L--11/Needles, Other (Nonhuman)
68L--12/Syringes, unfilled, general use (Nonhuman)
68L--13/Syringes, specialty, unfilled (Nonhuman)
68L--14/Syringes, Other (Nonhuman)
68L--15/Bandages, Gauze pads, plain (Nonhuman)
68L--16/Bandages, Gauze pads, non-stick (Nonhuman)
68L--17/Bandages, Roll (Nonhuman)
68L--18/Bandages, Other (Nonhuman)
68L--19/Cotton (Nonhuman)
68L--20/Drapes (Nonhuman)
68L--21/Feeding tubes (Nonhuman)
68L--22/Single-use surgical kits and instruments (Nonhuman)
68L--23/Sterile Flush solution (Nonhuman)
68L--24/Surgical Staples (Nonhuman)
68L--25/Suture in cassette (Nonhuman)
68L--26/Suture in individual package (Nonhuman)
68L--27/Tape (Nonhuman)
68L--99/Disposable/Sigle Use Devices, NEC (Nonhuman)
68M--01/Autoclave (Nonhuman)
68M--02/Biochemical Analyzer (Nonhuman)
68M--03/Cages, including oxygen cages (Nonhuman)
68M--04/Computed Tomography Equipment (Nonhuman)
68M--05/Doppler (Nonhuman)
68M--06/Electro-cardiogram (Nonhuman)
68M--07/Hematology Analyzer (Nonhuman)
68M--08/Infusion pumps (Nonhuman)
68M--09/Magnetic Resonance Imaging (Nonhuman)
68M--10/Scales (Nonhuman)
68M--11/Patient monitors (Nonhuman)
68M--12/Radiograph (X-ray) machine (Nonhuman)
68M--13/Tables-surgical, treatment, tub/table (Nonhuman)
68M--14/Treadmills (Nonhuman)
68M--15/Ultrasound (Nonhuman)
68M--16/Syringe pumps (Nonhuman)
68M--99/Large hospital/practice equipment, NEC (Nonhuman)
68N--01/Biopsy instruments (Nonhuman)
68N--02/Blood Pressure Monitoring equipment (Nonhuman)
68N--03/Centrifuge (Nonhuman)
68N--04/Drapes, Reusable (Nonhuman)
68N--05/Endoscope (Nonhuman)
68N--06/Glucose Monitoring Equipment (Nonhuman)
68N--07/Microchip reader (Nonhuman)
68N--08/Microscope (Nonhuman)
68N--09/Otoscope (Nonhuman)
68N--10/Pulse Oximeter (Nonhuman)
68N--11/Stethoscope (Nonhuman)
68N--12/Stapler (Nonhuman)
68N--13/Thermometers (Nonhuman)
68N--99/Small Hospital Practice Equipment, NEC (Nonhuman)
68O--01/Anesthesia machines (Nonhuman)
68O--02/Anesthesia machine parts and accessories (Nonhuman)
68O--03/Endotracheal tubes (Nonhuman)
68O--04/Laryngoscope (Nonhuman)
68O--05/Oxygen masks (Nonhuman)
68O--06/Patient ventilators (Nonhuman)
68O--99/Anesthesia Equipment, NEC (Nonhuman)
68P--01/Bone Pins (Nonhuman)
68P--02/Bone Plates (Nonhuman)
68P--03/Cast Material (Nonhuman)
68P--04/Cast Padding (Nonhuman)
68P--05/External Bone Fixation Devices and accessories (Nonhuman)
68P--06/Orthopedic Screws (Nonhuman)
68P--07/Orthopedic Wire (Nonhuman)
68P--08/Orthopedic Surgical Hand Tools (Nonhuman)
68P--09/Orthopedic Power tools (Nonhuman)
68P--10/Solutions (Nonhuman)
68P--11/Splints (Nonhuman)
68P--12/Stockinette (Nonhuman)
68P--99/Orthopedic, NEC (Nonhuman)
68Q--01/Catheter, Nasolacrimal (Nonhuman)
68Q--02/Cannula, Nasolacrimal (Nonhuman)
68Q--03/Eye Speculum (Nonhuman)
68Q--04/Lenses, Intraocular (Nonhuman)
68Q--05/Lenses, Contact (Nonhuman)
68Q--06/Ophthalmic Hand Tools, Other (Nonhuman)
68Q--07/Ophthalmoscopes (Nonhuman)
68Q--08/Sterile Solutions (Nonhuman)
68Q--09/Subpalpebral lavage and treatment systems (Nonhuman)
68Q--10/Tonometer (Nonhuman)
68Q--99/Ophthalmic Devices NEC (Nonhuman)
68R--01/Dental hand Tools, Other (Nonhuman)
68R--02/Elevators (Nonhuman)
68R--03/Forceps (Nonhuman)
68R--04/Hand Scalers (Nonhuman)
68R--05/Mouth Gag (Nonhuman)
68R--06/Speculum (Nonhuman)
68R--07/Tooth Floats and accessories (Nonhuman)
68R--08/Ultrasonic Scalers (Nonhuman)
68R--99/Dental devices NEC (Nonhuman)
68Z--99/Animal Medical Devices, NEC
Please send any questions or concerns to the email address for the Product Code Builder Feedback PCBFeedback@fda.hhs.gov
The Food and Drug Administration will be adding and ending CVM Class Codes and Product Codes under Industry Code 68, described below and in attached list.
The Class Code X will be end-dated in 30 days and expiring on April 15, 2019.
Class Code/Description
X/Device/Diag Prod For Animal
The Product Codes below will be end-dated in 30 days and expiring on April 15, 2019.
Product Code/Description
68X--01/Cattle Device/Diag Prod For Animal
68X--02/Horses Device/Diag Prod For Animal
68X--03/Poultry Device/Diag Prod For Animal
68X--04/Sheep Device/Diag Prod For Animal
68X--05/Swine Device/Diag Prod For Animal
68X--10/Small Animal Device/Diag Prod For Animal
68X--20/Device/Diag Prod For Animal Used More Than 1 Species
68X--99/Other Animal, N.E.C. Device/Diag Prod For Animal
The new Class Code S will be available in 30 days, on April 15, 2019
Class Code/Description
S/Diagnostics (in vivo, in vitro and NEC)-Nonhuman
The new Product Codes below will be available in 30 days, on April 15, 2019
Product Code/Description
68S--01/In Vitro Test Kits, Individual (Nonhuman)
68S--02/In Vitro Test Kits, Multi-patient (Nonhuman)
68S--03/In Vivo Test Kits, Individual (Nonhuman)
68S--04/In Vivo Test Kits, Multi-patient (Nonhuman)
68S--05/Replacement Chemicals for Serum Analyzers (Nonhuman)
68S--06/Replacement Chemicals for Hematology Analyzers (Nonhuman)
68S--07/Parasite Egg Flotation Solution (Nonhuman)
68S--08/Parasite Diagnostic Tools, Other (Nonhuman)
68S--99/Animal Diagnostics, NEC
The new Class Codes below are available immediately.
Class Code/Description
L/Disposables/single use devices-Nonhuman
M/Large hospital/clinic equipment-Nonhuman
N/Small hospital/clinic equipment-Nonhuman
O/Anesthesia-Nonhuman
P/Orthopedic-Nonhuman
Q/Ophthalmic-Nonhuman
R/Dental-Nonhuman
Z/Animal Medical Devices, NEC
The new Product Codes below are available immediately.
Product Code/Description
68L--01/Biopsy instruments, single use (Nonhuman)
68L--02/Blood tubes, plain (Nonhuman)
68L--03/Blood tubes with additive (Nonhuman)
68L--04/Blood collection bags, tubing and accessories (Nonhuman)
68L--05/Catheters, Intravenous (Nonhuman)
68L--06/Catheters, Urinary (Nonhuman)
68L--07/Catheters, Other (Nonhuman)
68L--08/Fluid administration tubing, sets, and related accessories (Nonhuman)
68L--09/Needles for injection (Nonhuman)
68L--10/Needles for suture (Nonhuman)
68L--11/Needles, Other (Nonhuman)
68L--12/Syringes, unfilled, general use (Nonhuman)
68L--13/Syringes, specialty, unfilled (Nonhuman)
68L--14/Syringes, Other (Nonhuman)
68L--15/Bandages, Gauze pads, plain (Nonhuman)
68L--16/Bandages, Gauze pads, non-stick (Nonhuman)
68L--17/Bandages, Roll (Nonhuman)
68L--18/Bandages, Other (Nonhuman)
68L--19/Cotton (Nonhuman)
68L--20/Drapes (Nonhuman)
68L--21/Feeding tubes (Nonhuman)
68L--22/Single-use surgical kits and instruments (Nonhuman)
68L--23/Sterile Flush solution (Nonhuman)
68L--24/Surgical Staples (Nonhuman)
68L--25/Suture in cassette (Nonhuman)
68L--26/Suture in individual package (Nonhuman)
68L--27/Tape (Nonhuman)
68L--99/Disposable/Sigle Use Devices, NEC (Nonhuman)
68M--01/Autoclave (Nonhuman)
68M--02/Biochemical Analyzer (Nonhuman)
68M--03/Cages, including oxygen cages (Nonhuman)
68M--04/Computed Tomography Equipment (Nonhuman)
68M--05/Doppler (Nonhuman)
68M--06/Electro-cardiogram (Nonhuman)
68M--07/Hematology Analyzer (Nonhuman)
68M--08/Infusion pumps (Nonhuman)
68M--09/Magnetic Resonance Imaging (Nonhuman)
68M--10/Scales (Nonhuman)
68M--11/Patient monitors (Nonhuman)
68M--12/Radiograph (X-ray) machine (Nonhuman)
68M--13/Tables-surgical, treatment, tub/table (Nonhuman)
68M--14/Treadmills (Nonhuman)
68M--15/Ultrasound (Nonhuman)
68M--16/Syringe pumps (Nonhuman)
68M--99/Large hospital/practice equipment, NEC (Nonhuman)
68N--01/Biopsy instruments (Nonhuman)
68N--02/Blood Pressure Monitoring equipment (Nonhuman)
68N--03/Centrifuge (Nonhuman)
68N--04/Drapes, Reusable (Nonhuman)
68N--05/Endoscope (Nonhuman)
68N--06/Glucose Monitoring Equipment (Nonhuman)
68N--07/Microchip reader (Nonhuman)
68N--08/Microscope (Nonhuman)
68N--09/Otoscope (Nonhuman)
68N--10/Pulse Oximeter (Nonhuman)
68N--11/Stethoscope (Nonhuman)
68N--12/Stapler (Nonhuman)
68N--13/Thermometers (Nonhuman)
68N--99/Small Hospital Practice Equipment, NEC (Nonhuman)
68O--01/Anesthesia machines (Nonhuman)
68O--02/Anesthesia machine parts and accessories (Nonhuman)
68O--03/Endotracheal tubes (Nonhuman)
68O--04/Laryngoscope (Nonhuman)
68O--05/Oxygen masks (Nonhuman)
68O--06/Patient ventilators (Nonhuman)
68O--99/Anesthesia Equipment, NEC (Nonhuman)
68P--01/Bone Pins (Nonhuman)
68P--02/Bone Plates (Nonhuman)
68P--03/Cast Material (Nonhuman)
68P--04/Cast Padding (Nonhuman)
68P--05/External Bone Fixation Devices and accessories (Nonhuman)
68P--06/Orthopedic Screws (Nonhuman)
68P--07/Orthopedic Wire (Nonhuman)
68P--08/Orthopedic Surgical Hand Tools (Nonhuman)
68P--09/Orthopedic Power tools (Nonhuman)
68P--10/Solutions (Nonhuman)
68P--11/Splints (Nonhuman)
68P--12/Stockinette (Nonhuman)
68P--99/Orthopedic, NEC (Nonhuman)
68Q--01/Catheter, Nasolacrimal (Nonhuman)
68Q--02/Cannula, Nasolacrimal (Nonhuman)
68Q--03/Eye Speculum (Nonhuman)
68Q--04/Lenses, Intraocular (Nonhuman)
68Q--05/Lenses, Contact (Nonhuman)
68Q--06/Ophthalmic Hand Tools, Other (Nonhuman)
68Q--07/Ophthalmoscopes (Nonhuman)
68Q--08/Sterile Solutions (Nonhuman)
68Q--09/Subpalpebral lavage and treatment systems (Nonhuman)
68Q--10/Tonometer (Nonhuman)
68Q--99/Ophthalmic Devices NEC (Nonhuman)
68R--01/Dental hand Tools, Other (Nonhuman)
68R--02/Elevators (Nonhuman)
68R--03/Forceps (Nonhuman)
68R--04/Hand Scalers (Nonhuman)
68R--05/Mouth Gag (Nonhuman)
68R--06/Speculum (Nonhuman)
68R--07/Tooth Floats and accessories (Nonhuman)
68R--08/Ultrasonic Scalers (Nonhuman)
68R--99/Dental devices NEC (Nonhuman)
68Z--99/Animal Medical Devices, NEC
Please send any questions or concerns to the email address for the Product Code Builder Feedback PCBFeedback@fda.hhs.gov
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