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…
- GMDN category: CPAP/BiPAP nasal mask, single-use
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.