NMC

Mask, Ventilator, Non-Continuous, Reprocessed

Product code

NMC

Device name

Mask, Ventilator, Non-Continuous, Reprocessed

Device class

Class 2

21 CFR

21 CFR 868.5905

Medical specialty

Anesthesiology

Marketing pathway

510(K)

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).