Product code NZU

Device name

Collector, Urine, Powered, Non Indwelling Catheter

Medical specialty

Gastroenterology, Urology

Device class

1

Regulation number

876.5250

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

Y

Third party review

N

Summary malfunction reporting

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.

Source

FDA openFDA device classification dataset