Device Dossier

CPAP/BiPAP face mask, reusable

Device Dossier for CPAP/BiPAP face mask, reusable (CPAP/BiPAP face mask, reusable, Class IIa, sponsor Sefam Medical). ARTG record, intended purpose, GMDN…

Intended purpose

A reusable facial mask designed for non invasive ventilation via the use of a barometric device delivering continuous positive airway pressure (CPAP) or bi-level pressure (BiPAP)

TGA Public Summary