FDA product code NZU

Collector, Urine, Powered, Non Indwelling Catheter

Gastroenterology, Urology·Class 1·21 CFR 876.5250
US regulatory classifications
US Product Code (FDA)
NZU
View Product Code Classification →
US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 876.5250
View CFR Regulation →
Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
Yes
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

For the non-invasive, non-sterile collection of urine and for patients unable to void on their own or have control of voiding. Often patient confined to the bed or a wheelchair.

Search keywords
About this record

Collector, Urine, Powered, Non Indwelling Catheter is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.