Device Dossier

Mask, non-rebreathing, air/oxygen

Device Dossier for Mask, non-rebreathing, air/oxygen (Mask, non-rebreathing, air/oxygen, Class IIa, sponsor Flexicare). ARTG record, intended purpose,…

Intended purpose

To be placed over the nose and mouth to deliver a high concentration of oxygen mixed with air to a patient's airway. Provides a high concentration of oxygen, whilst the reservoir bag allows for adequate oxygen to be available in order to meet unpredictable patients breathing patterns and tidal volumes.

TGA Public Summary