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 Philips Electronics). ARTG record, intended…
- GMDN category: CPAP/BiPAP face mask, single-use
Intended purpose
The mask is intended to provide an interface for application of non-invasive positive airway pressure delivered to patients by a device such as a CPAP or bi-level system. It is available in various designs and sizes and stabilized with a headstrap. The mask is for single use in the hospital/institutional environment only.