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Resuscitator, pulmonary, manual, single use - ARTG 327846

Access comprehensive regulatory information for Resuscitator, pulmonary, manual, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 327846 and sponsored by Quest Surgical Pty Ltd, manufactured by Mercury Medical in United States of America. The device registration started on December 17, 2019.

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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Class IIa
ARTG 327846
Class IIa
Resuscitator, pulmonary, manual, single use
ARTG ID: 327846
Good Name: Quest Surgical Pty Ltd - Resuscitator, pulmonary, manual, single use
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Intended Purpose

The Neo-Tee Resuscitator mask is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask. It is intended for single use with neonates and infants weighing less than 10kg.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
327846
Start Date
December 17, 2019
Effective Date
December 17, 2019
Manufacturer
Country
United States of America
Address
11300 49th Street North, Clearwater, FL, 33762