Australia TGA ARTG record

Analyser, blood gas, extracorporeal

Australia TGA ARTG Registered Device · Terumo Australia Pty Ltd · Terumo Cardiovascular Systems Corporation · Class IIb · Started October 29, 2020

Good Name: Terumo Australia Pty Ltd - Analyser, blood gas, extracorporeal

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: October 29, 2020
Effective Date: October 29, 2020

Sponsor

Name: Terumo Australia Pty Ltd

Manufacturer

Name: Terumo Cardiovascular Systems Corporation
Country: United States of America
Address: 6200 Jacksons Road, ANN ARBOR, MICHIGAN, 48103

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 37°C. For documentation purposes, the systems integral printer provides a hard copy of displayed parameters.

About this record

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 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.