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 Emergo). ARTG record, intended purpose, GMDN…

Intended purpose

The masks channel airflow from ventilator systems non-invasively to patients who suffer from obstructive sleep apnea (OSA) or respiratory insufficiency and respiratory failure. The masks are to be used by adult patients (greater than 30 kg) requiring non-life-support ventilator assistance. The masks are intended for single-patient use, for a maximum of seven days, in the hospital or clinical environment.

TGA Public Summary