Bag, Urine Collection, Leg, For External Use, Non-Sterile
The non-sterile leg-worn urine collection bag for external use is a urological device designed to collect urine from patients using external urinary catheters or sheaths, worn discreetly on the leg. It is classified as FDA Class 1 under regulation 876.5250 in the Gastroenterology and Urology specialty, and it is GMP exempt. Product code NNW does not require a 510(k) submission and is associated with product code FAQ.
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Basic Information
- Product Code
- NNW
- Device Class
- FDA class 1
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
Definition
Urine collector and accessories; see product code FAQ.
FEI Numbers
This FDA classification entry is associated with 97 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 97 registration numbers. Click on an entry to view related FDA registrations.