Catheter Care Tray
The Catheter Care Tray is a convenience kit containing supplies used to clean and maintain urinary or vascular catheters, supporting infection prevention and catheter site care. Classified as FDA Class 2 under regulation 21 CFR 876.5130 within the Gastroenterology and Urology medical specialty, it is under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) when all criteria are satisfied. The product code is OHR. It is not flagged as an implant or life-sustaining device.
Research product code OHR in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OHR
- Device Class
- FDA class 2
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
FEI Numbers
This FDA classification entry is associated with 40 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 40 registration numbers. Click on an entry to view related FDA registrations.