ARTG 461527CDI OneView Monitoring System - Analyser, blood gas, extracorporeal
ARTG ID: 461527 · Terumo Australia Pty Ltd · Terumo Cardiovascular Systems Corporation · Class IIb · Started August 30, 2024
Good Name: Terumo Australia Pty Ltd - CDI OneView Monitoring System - Analyser, blood gas, extracorporeal
- Risk Class
- Class IIb
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 461527
- Start Date
- August 30, 2024
- Effective Date
- August 30, 2024
- Country
- United States of America
- Address
- 6200 Jacksons Road, ANN ARBOR, MICHIGAN, 48103
A patient parameter monitoring system to be used on a single patient during cardiopulmonary bypass procedures. By measurement or acquisition from other devices, it displays and outputs information to provide continuous, in-line monitoring of various patient parameters contained within the extracorporeal perfusion circuit and patient. The following parameters are available, based on configuration: Potential of Hydrogen pH, Partial Pressure of Carbon Dioxide (pCO2), Partial Pressure of Oxygen (pO2), Potassium Ion (K+), Oxygen Saturation (SO2), Haematocrit (HCT), Haemoglobin (Hgb), Blood Flowrate (Q), Cardiac Index (CI), Base Excess (BE), ꞏ Bicarbonate (HCO−3), Oxygen Consumption (VO2), Indexed Oxygen Consumption (VO2i), Oxygen Delivery (DO2), Indexed Oxygen Delivery (DO2i), Cerebral regional oxygen saturation (rSO2), Oxygen Extraction Ratio (O2ER), Body Surface Area (BSA), Shunt Sensor Temperature.
Access comprehensive regulatory information for CDI OneView Monitoring System - 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 461527 and sponsored by Terumo Australia Pty Ltd, manufactured by Terumo Cardiovascular Systems Corporation in United States of America. The device registration started on August 30, 2024.
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.