Device Dossier

CPAP/BiPAP nasal mask, reusable

Device Dossier for CPAP/BiPAP nasal mask, reusable (CPAP/BiPAP nasal mask, reusable, Class IIa, sponsor Boian Surgical). ARTG record, intended purpose,…

Intended purpose

A flexible device designed to deliver continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP), via a nose interface, to the respiratory tract with direct ambient air, or medical oxygen (O2) and air, for non-invasive positive pressure ventilation (NPPV).

TGA Public Summary