FDA product code NNZ: System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile
NNZ is the FDA product code for system, urine drainage, closed, for non-indwelling catheter, non-sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel. Devices under NNZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for NNZ devices.
Definition
Urine collector and accessories; see product code EYZ.
Classification
| Field | Value |
|---|---|
| Device name | System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile |
| Device class | Class I |
| Regulation | 21 CFR 876.5250 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for NNZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-07-10.
Frequently asked questions
What is FDA product code NNZ?
NNZ is the FDA product code for system, urine drainage, closed, for non-indwelling catheter, non-sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel.
What device class is NNZ?
Class I, regulation 21 CFR 876.5250. Typical premarket route: 510(k) exempt.
Have NNZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-07-10.
Next steps
- Run an FDA pathway report with predicate devices for product code NNZ
- Run a recall and safety report across every NNZ manufacturer
- Watch product code NNZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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