NZUClass I
Collector, Urine, Powered, Non Indwelling Catheter
21 CFR 876.5250 / Gastroenterology, Urology
NZU is the FDA product code for Collector, Urine, Powered, Non Indwelling Catheter, a class I device type, regulated under 21 CFR 876.5250. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.
Classification record
- Product code
- NZU
- Device name
- Collector, Urine, Powered, Non Indwelling Catheter
- FDA 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.
- Regulation
- 21 CFR 876.5250
- Device class
- Class I
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 1
Clearances, product code NZU
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2006 | 1 |
Applicants with the most clearances
Product code NZU| Applicant | Clearances |
|---|---|
| Preferred Medical Devices, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.