Device Dossier

CPAP/BiPAP nasal mask, single-use

Device Dossier for CPAP/BiPAP nasal mask, single-use (CPAP/BiPAP nasal mask, single-use, Class IIa, sponsor Intersurgical). ARTG record, intended…

Intended purpose

The BiTrac Nasal mask is a comfortable and effective solution for non-invasive ventilation. Designed with a double-lipped silicone cushion, the BiTrac Nasal helps alleviate unnecessary pressure while achieving a great seal. The OmniClip technology allows for adjustable forehead pad positioning, while the headgear's two sets of Velcro ensure a perfect fit for patients of all head sizes.

TGA Public Summary