Mask, air/oxygen
Access comprehensive regulatory information for Mask, air/oxygen in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia, manufactured by Hsiner Co Ltd in Taiwan. The device registration started on March 30, 2021.
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.
A malleable cylinder placed over the nose and mouth intended to deliver air/oxygen gases to a patient's airway in critical care areas, home care, hyperbaric chamber and any respiratory care environments. This device is typically non-conductive and is available in a range of sizes. It may include a head strap and various connectors and valves. It is available in autoclavable reusable version and autoclavable single patient use (SPU) version. However, the SPU Version can only be re-used repeatedly on a single patient. More specifically the masks are used for Non-Invasive Ventilation (NIV) through Ventilation devices including Bi-Level Positive Airway Pressure (BIPAP), All Continuous Positive Airway Pressure (CPAP) devices, Home Care Ventilators (HC), Intensive Care (ICU) Ventilators, Hyperbaric Chamber and other critical care ventilators.