Device Dossier
CPAP/BiPAP face mask, reusable
Device Dossier for CPAP/BiPAP face mask, reusable (CPAP/BiPAP face mask, reusable, Class IIa, sponsor Plus Medical). ARTG record, intended purpose, GMDN…
- GMDN category: CPAP/BiPAP face mask, reusable
Intended purpose
Sleep apnea breathing mask, CPAP/BiPAP masks are used in conjunction with CPAP and BiPAP. The masks are flexible, face and form-shaped devices designed to be placed over a client's nose and mouth to interface with a CPAP or BiPAP unit. They create an airtight seal around the nose and mouth. They are available in various designs and sizes and are stabilized with a head and/or chin strap. This is a reusable device.