FDA product code NNW: Bag, Urine Collection, Leg, For External Use, Non-Sterile
NNW is the FDA product code for bag, urine collection, leg, for external use, non-sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel. Devices under NNW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for NNW devices.
Definition
Urine collector and accessories; see product code FAQ.
Classification
| Field | Value |
|---|---|
| Device name | Bag, Urine Collection, Leg, For External Use, 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 NNW devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-02-24.
Frequently asked questions
What is FDA product code NNW?
NNW is the FDA product code for bag, urine collection, leg, for external use, 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 NNW?
Class I, regulation 21 CFR 876.5250. Typical premarket route: 510(k) exempt.
Have NNW devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2016-02-24.
Next steps
- Run an FDA pathway report with predicate devices for product code NNW
- Run a recall and safety report across every NNW manufacturer
- Watch product code NNW 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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