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Air heating/cooling pad, single-use, non-sterile - ARTG 482789

Access comprehensive regulatory information for Air heating/cooling pad, single-use, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 482789 and sponsored by Fairmont Medical Products Pty Ltd, manufactured by Gentherm Medical LLC in United States of America. The device registration started on March 17, 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 I
ARTG 482789
Class I
Air heating/cooling pad, single-use, non-sterile
ARTG ID: 482789
Good Name: Fairmont Medical Products Pty Ltd - Air heating/cooling pad, single-use, non-sterile
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Intended Purpose

A single use pad used on the head (wrap) or body (vest) which passes warmed or cooled water through the pad to transfer heat to/from the patient.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
482789
Start Date
March 17, 2025
Effective Date
March 17, 2025
Manufacturer
Country
United States of America
Address
12011 Mosteller Rd Cincinnati, Ohio, 45241