Device Dossier

CPAP/BiPAP nasal mask, single-use

Device Dossier for CPAP/BiPAP nasal mask, single-use (CPAP/BiPAP nasal mask, single-use, Class IIa, sponsor Drive Devilbiss). ARTG record, intended…

Intended purpose

A flexible device designed to be placed over a user's nose 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.

TGA Public Summary