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 Fisher & Paykel Healthcare). ARTG record,…

Intended purpose

The mask is used in conjunction with a CPAP device to deliver nasal CPAP respiratory gases to an infant patient via application of the mask to the patient's nose and creating an air seal around the patient's nose. The mask is 'single patient use' and is intended for single/short term use. Use of the mask is as prescribed by a physician.

TGA Public Summary