FDA product code NNG: Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed
NNG is the FDA product code for set, dialysis, single needle with uni-directional pump, reprocessed. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. Devices under NNG reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for NNG devices
openFDA lists no recalls for product code NNG.
Frequently asked questions
What is FDA product code NNG?
NNG is the FDA product code for set, dialysis, single needle with uni-directional pump, reprocessed. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is NNG?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NNG
- Run a recall and safety report across every NNG manufacturer
- Watch product code NNG 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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