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 Intersurgical). ARTG record, intended purpose,…
- GMDN category: CPAP/BiPAP face mask, single-use
Intended purpose
The mask intended to provide an interface for application of non-invasive positive airway pressure delivered to patient by a device such as a CPAP, bi-level or ventilator system. It is available in various designs and sizes and stabilized with a head strap. The mask is for single use in the hospital/ institutional environment only.