CPAP/BiPAP face mask, single-use

Intended purpose

Intended to provide a patient interface for application of non-invasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency or obstructive sleep apnoea. The mask is for single use in the hospital/ institutional environment only. Small and Medium Sizes: The mask is to be used on patients 7 years or older (>20 kg) who are appropriate candidates for non-invasive ventilation. Large and Extra-Large Sizes: The mask is to be used on patients (>30 kg) who are appropriate candidates for non-invasive ventilation.