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Patient monitor, multiparameter, transportable - ARTG 338416

Access comprehensive regulatory information for Patient monitor, multiparameter, transportable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 338416 and sponsored by Baxter Healthcare Pty Ltd, manufactured by Cheetah Medical Israel Ltd in Israel. The device registration started on June 26, 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 IIa
ARTG 338416
Class IIa
Patient monitor, multiparameter, transportable
ARTG ID: 338416
Good Name: Baxter Healthcare Pty Ltd - Patient monitor, multiparameter, transportable
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Intended Purpose

The Starling SV with NIBP and SpO2 functionalities is a portable, hemodynamic non-invasive Cardiac Output device that measures and displays a patientโ€™s Cardiac Output (CO) in Ltr/Min with a Non-Invasive Blood Pressure (NIBP) function that non-invasively measures and displays blood pressure (diastolic, systolic and mean arterial pressure) and heart rate and with a SpO2 function that non-invasively measures and displays blood oxygen saturation (SpO2).ย ย  The device displays associated hemodynamic parameters based on measurements or calculations of measurements already incorporated into the Starling SV. The monitor is not used to monitor vital physiological parameters of a patient.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
338416
Start Date
June 26, 2020
Effective Date
June 26, 2020
Manufacturer
Country
Israel
Address
2A Hashlosha St F-32, Tel Aviv, Israel, 6706055