CPAP/BiPAP face mask, single-use
Access comprehensive regulatory information for CPAP/BiPAP face mask, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Intersurgical Australia Pty Ltd, manufactured by Pulmodyne Inc in United States of America. The device registration started on January 11, 2022.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
The mask intended to provide an interface for application of non-invasive positive airway pressure delivered to patient by a device such as a CPAP, bi-level or ventilator system. It is available in various designs and sizes and stabilized with a head strap. The mask is for single use in the hospital/ institutional environment only.