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Oxygen/air breathing gas mixer - ARTG 482239

Access comprehensive regulatory information for Oxygen/air breathing gas mixer in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 482239 and sponsored by Fisher & Paykel Healthcare Pty Ltd, manufactured by Maxtec LLC in United States of America. The device registration started on March 12, 2025.

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 IIb
ARTG 482239
Class IIb
Oxygen/air breathing gas mixer
ARTG ID: 482239
Good Name: Fisher & Paykel Healthcare Pty Ltd - Oxygen/air breathing gas mixer
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Intended Purpose

To dispense a continuous and precise blend of medical air and oxygen via outlet ports.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
482239
Start Date
March 12, 2025
Effective Date
March 12, 2025
Manufacturer
Country
United States of America
Address
2305 South 1070 West, Salt Lake City, UT, 84119