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NMCClass II

Mask, Ventilator, Non-Continuous, Reprocessed

21 CFR 868.5905 / Anesthesiology
FDA source (opens on fda.gov)

NMC is the FDA product code for Mask, Ventilator, Non-Continuous, Reprocessed, a class II device type, regulated under 21 CFR 868.5905. FDA's definition for this code reads: "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)". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NMC
Device name
Mask, Ventilator, Non-Continuous, Reprocessed
FDA 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).
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NMC.