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Analyser, blood gas, extracorporeal - ARTG 346730

Access comprehensive regulatory information for Analyser, blood gas, extracorporeal in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 346730 and sponsored by Terumo Australia Pty Ltd, manufactured by Terumo Cardiovascular Systems Corporation in United States of America. The device registration started on October 29, 2020.

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 346730
Class IIb
Analyser, blood gas, extracorporeal
ARTG ID: 346730
Good Name: Terumo Australia Pty Ltd - Analyser, blood gas, extracorporeal
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Intended Purpose

An instrument that provides continuous on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, haematocrit, haemoglobin and temperature. Additional calculated values of base excess, bicarbonate, oxygen saturation, oxygen delivery and oxygen consumption may also be provided. Parameters are displayed at either actual temperature or adjusted to 37ยฐC. For documentation purposes, the systems integral printer provides a hard copy of displayed parameters.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
346730
Start Date
October 29, 2020
Effective Date
October 29, 2020
Manufacturer
Country
United States of America
Address
6200 Jacksons Road, ANN ARBOR, MICHIGAN, 48103