Collector, Urine, Powered, Non Indwelling Catheter

What Is It?

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.

How Is NZU Classified?

Collector, Urine, Powered, Non Indwelling Catheter is FDA product code NZU, Class 1, 21 CFR 876.5250.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2023. None was by a company in China. The root cause the FDA records most often is Process change control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.