Device Dossier
CPAP/BiPAP nasal mask, reusable
Device Dossier for CPAP/BiPAP nasal mask, reusable (CPAP/BiPAP nasal mask, reusable, Class IIa, sponsor Philips Electronics). ARTG record, intended…
- GMDN category: CPAP/BiPAP nasal mask, reusable
Intended purpose
The mask is intended to provide an interface for application of non-invasive ventilation to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients 5 kg/11 lbs or greater for whom non-invasive ventilation has been prescribed.