Device Dossier
CPAP/BiPAP face mask, single-use
Device Dossier for CPAP/BiPAP face mask, single-use (CPAP/BiPAP face mask, single-use, Class IIb, sponsor Device Technologies). ARTG record, intended…
- GMDN category: CPAP/BiPAP face mask, single-use
- Sponsor: Device Technologies
Intended purpose
A non-sterile, single patient device that typically provides an airtight seal over the nose and mouth of the patient and interfaces with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP) unit. This results in noninvasive positive pressure ventilation (NPPV) to the patient using ambient air or medical oxygen.