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Oesophageal intubation detector, exhaled carbon dioxide, adult

Access comprehensive regulatory information for Oesophageal intubation detector, exhaled carbon dioxide, adult in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Im is sponsored by Intersurgical Australia Pty Ltd, manufactured by Pulmodyne Inc in United States of America. The device registration started on February 22, 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 Im
Class Im
Oesophageal intubation detector, exhaled carbon dioxide, adult
Australia TGA ARTG Registered Device
Good Name: Intersurgical Australia Pty Ltd - Oesophageal intubation detector, exhaled carbon dioxide, adult
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Intended Purpose

To indicate the approximate ranges of end-tidal CO2 by color comparison when connected to the exhalation port of a resuscitation bag or during endotracheal or nasotra-cheal intubation.

Device Classification
Risk Class
Class Im
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
February 22, 2022
Effective Date
February 22, 2022
Manufacturer
Country
United States of America
Address
2055 Executive Drive, Indianapolis, IN, 46241