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 Drive Devilbiss). ARTG record, intended…
- GMDN category: CPAP/BiPAP face mask, single-use
Intended purpose
A flexible device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure to provide the respiratory tract with direct ambient air at a higher pressure. It is typically made of plastic/silicone materials and available in various designs and sizes and stabilized with a head strap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.