Collector, Urine, Powered, Non Indwelling Catheter
NZU · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.5250
Classification
FDA Product Code
NZU
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 876.5250
Review panel
GU
Medical specialty
Gastroenterology, Urology
Submission type
4
GMP exempt
Y
Life sustaining
N
Implant
N
Third-party review
N
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.