Australia TGA ARTG record

Half-face respirator body/filter

Australia TGA ARTG Registered Device · Dexcon Pty Ltd · Reusable Respirators LCC · Class I · Started April 16, 2024

Good Name: Dexcon Pty Ltd - Half-face respirator body/filter

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: April 16, 2024
Effective Date: April 16, 2024

Sponsor

Name: Dexcon Pty Ltd

Manufacturer

Name: Reusable Respirators LCC
Country: United States of America
Address: 430 West 5th Street Suite 105, Panama City, Florida, 32401

Intended purpose

A filter that is designed to be used with a surgical/medical facepiece. When filters are combined with the facepiece, the device becomes a respirator. The respirator is designed to be placed over the mouth and nose of a healthcare worker 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 are reusable and replaceable. It might incorporate a forming nosepiece (metal wire) and or an exhalation valve.

About this record

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 16, 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.