Device Dossier

Mask, non-rebreathing, air/oxygen

Device Dossier for Mask, non-rebreathing, air/oxygen (Mask, non-rebreathing, air/oxygen, Class IIb, sponsor Medline International Two). ARTG record,…

Intended purpose

Intended to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. This is a single-use device.

TGA Public Summary