Device Dossier

Home BPAP unit

Device Dossier for Home BPAP unit (Home BPAP unit, Class IIa, sponsor Emergo). ARTG record, intended purpose, GMDN category — compiled by arcimedes.

Intended purpose

The BPAP System is a Bi-level Positive Airway Pressure device, which is intended to provide non-invasive ventilation for patients with obstructive sleep apnea (OSA) and Respiratory Insufficiency. These devices are intended for adult patients by prescription in the home or hospital/institutional environment.

TGA Public Summary