Device Dossier

CPAP/BiPAP nasal mask, single-use

Device Dossier for CPAP/BiPAP nasal mask, single-use (CPAP/BiPAP nasal mask, single-use, Class IIa, sponsor Intersurgical). ARTG record, intended…

Intended purpose

To provide continuous positive airway pressure (CPAP), bi-level positive airway pressure (BPAP) or higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV) with direct ambient air, or medical oxygen (O2) and air, via a seal around the nose. It is stabilised with a headstrap, headgear or bonnet.

TGA Public Summary