Device Dossier

CPAP/BiPAP nasal mask, reusable

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

Intended purpose

Youth Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients 7 years or older (>40 lbs/18 kg) for whom CPAP or bi-level therapy has been prescribed.

TGA Public Summary