FDA product code PUG: Analyzer, Nitrogen Dioxide, Exempt
PUG is the FDA product code for analyzer, nitrogen dioxide, exempt. It is a Class II device, regulated under 21 CFR 868.2385 and reviewed by the Anesthesiology panel. Devices under PUG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code is the class II exempt counterpart of MRQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 868.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Nitrogen Dioxide, Exempt |
| Device class | Class II |
| Regulation | 21 CFR 868.2385 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
| Life-sustaining or supporting | Yes |
Recalls for PUG devices
openFDA lists no recalls for product code PUG.
Frequently asked questions
What is FDA product code PUG?
PUG is the FDA product code for analyzer, nitrogen dioxide, exempt. It is a Class II device, regulated under 21 CFR 868.2385 and reviewed by the Anesthesiology panel.
What device class is PUG?
Class II, regulation 21 CFR 868.2385. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PUG
- Run a recall and safety report across every PUG manufacturer
- Watch product code PUG 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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