Device Dossier

Mask, air/oxygen

Device Dossier for Mask, air/oxygen (Mask, air/oxygen, Class IIa, sponsor Draeger). ARTG record, intended purpose, GMDN category — compiled by arcimedes.

Intended purpose

The ClassicStar single-patient use NIV(non-invasive ventilation) Mask is intended to provide a patient interface for application of non-invasive ventilation. The mask is to be used as an accessory to ventilators that have appropriate alarms and safety systems for ventilator failure, and which are intended to administer CPAP (Continuous Positive Airway Pressure)or positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency.

TGA Public Summary