FDA product code NMC: Mask, Ventilator, Non-Continuous, Reprocessed
NMC is the FDA product code for mask, ventilator, non-continuous, reprocessed. It is a Class II device, regulated under 21 CFR 868.5905 and reviewed by the Anesthesiology panel. Devices under NMC reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Reprocessed mask for use with a non-continuous ventilator (CPAP, BiLevel pressure). 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 | Mask, Ventilator, Non-Continuous, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 868.5905 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
Recalls for NMC devices
openFDA lists no recalls for product code NMC.
Frequently asked questions
What is FDA product code NMC?
NMC is the FDA product code for mask, ventilator, non-continuous, reprocessed. It is a Class II device, regulated under 21 CFR 868.5905 and reviewed by the Anesthesiology panel.
What device class is NMC?
Class II, regulation 21 CFR 868.5905. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NMC
- Run a recall and safety report across every NMC manufacturer
- Watch product code NMC 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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