Australia TGA ARTG recordCPAP/BiPAP face mask, single-use
Australia TGA ARTG Registered Device · Intersurgical Australia Pty Ltd · Sleepnet Corporation · Class IIa · Started July 23, 2020
Good Name: Intersurgical Australia Pty Ltd - CPAP/BiPAP face mask, single-use
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- July 23, 2020
- Effective Date
- July 23, 2020
- Country
- United States of America
- Address
- 5 Merrill Industrial Drive, Hampton, NH, 03842
A flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). Creates a seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap.
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 Sleepnet Corporation in United States of America. The device registration started on July 23, 2020.
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.