Device Dossier
CPAP/BiPAP face mask, reusable
Device Dossier for CPAP/BiPAP face mask, reusable (CPAP/BiPAP face mask, reusable, Class IIb, sponsor Meditech Systems). ARTG record, intended purpose,…
- GMDN category: CPAP/BiPAP face mask, reusable
Intended purpose
CPAP/BiPAP masks are used in conjunction with CPAP and BiPAP therapy for patients who need help recruiting or splinting open their airways. The masks are flexible, face and form-shaped devices designed to be placed over a client's nose and mouth to interface with the aforementioned 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.