Device Dossier
CPAP/BiPAP face mask, single-use
Device Dossier for CPAP/BiPAP face mask, single-use (CPAP/BiPAP face mask, single-use, Class IIa, sponsor Lowenstein Medical). ARTG record, intended…
- GMDN category: CPAP/BiPAP face mask, single-use
Intended purpose
A non sterile, flexible, form shaped device designed to be placed over a users nose and mouth to interface with CPAP or BPAP unit to provide the respiratory tract with direct ambient air, or medical oxygen and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation.