Half-face respirator body/filter - ARTG 445233
Access comprehensive regulatory information for Half-face respirator body/filter in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 445233 and sponsored by Dexcon Pty Ltd, manufactured by Reusable Respirators LCC in United States of America. The device registration started on April 04, 2024.
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 form-shaped facepiece body only, developed to be worn in conjunction with filtering pucks. When the facepiece is combined with filters, the device becomes a respirator. The respirator is designed to be placed over the mouth and nose of healthcare workers and permits normal breathing. It protects the wearer and the patient from large and small particles during medical, surgical, dental and isolation procedures: it does not include antimicrobial agents(s). It is designed to create an airtight seal against the user’s face, and typically includes ties and head straps: filters might be replaceable. It might incorporate a forming nosepiece (metal wire) and or an exhalation valve. This is a reusable device after appropriate cleaning.