Device Dossier

CPAP/BiPAP face mask, reusable

Device Dossier for CPAP/BiPAP face mask, reusable (CPAP/BiPAP face mask, reusable, Class IIb, sponsor Parker Healthcare). ARTG record, intended purpose,…

Intended purpose

Mask covers the mouth and nose and is used to connect with a CPAP or BPAP unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation. This is a reusable device.

TGA Public Summary