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Aerosol face mask, rebreathing

Access comprehensive regulatory information for Aerosol face mask, rebreathing in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Medline International Two Australia Pty Ltd, manufactured by Teleflex Medical in United States of America. The device registration started on August 09, 2022.

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Aerosol face mask, rebreathing
Australia TGA ARTG Registered Device
Good Name: Medline International Two Australia Pty Ltd - Aerosol face mask, rebreathing
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Intended Purpose

Aerosol masks are single use devices that fit over the nose and mouth of a patient and are intended to deliver aerosol therapy to the patient for inhalation of nebulized medications or for humidification of the respiratory tract.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 09, 2022
Effective Date
August 09, 2022
Manufacturer
Country
United States of America
Address
3015 Carrington Mill Boulevard, Morrisville, NC, 27560