NZU

Collector, Urine, Powered, Non Indwelling Catheter

Product code

NZU

Device name

Collector, Urine, Powered, Non Indwelling Catheter

Device class

Class 1

21 CFR

21 CFR 876.5250

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K) Exempt

Flag

GMP exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).