Australia TGA ARTG recordHalf-face respirator body/filter
Australia TGA ARTG Registered Device · Dexcon Pty Ltd · Reusable Respirators LCC · Class I · Started April 04, 2024
Good Name: Dexcon Pty Ltd - Half-face respirator body/filter
- Risk Class
- Class I
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- April 04, 2024
- Effective Date
- April 04, 2024
- Name
- Dexcon Pty Ltd
- Country
- United States of America
- Address
- 430 West 5th Street Suite 105, Panama City, Florida, 32401
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.
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 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.