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Oxygen/air breathing gas mixer - ARTG 465106

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 I is registered under ARTG number 465106 and sponsored by Fisher & Paykel Healthcare Pty Ltd, manufactured by Maxtec LLC in United States of America. The device registration started on October 21, 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.

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TGA ARTG Official Data
Class I
ARTG 465106
Class I
Oxygen/air breathing gas mixer
ARTG ID: 465106
Good Name: Fisher & Paykel Healthcare Pty Ltd - Oxygen/air breathing gas mixer
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Intended Purpose

To be attached to the Flowmeter to reduce the noise produced by the gas exchange blend.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
465106
Start Date
October 21, 2024
Effective Date
October 21, 2024
Manufacturer
Country
United States of America
Address
2305 South 1070 West, Salt Lake City, UT, 84119