Fluid Management Monitoring System - India CDSCO Medical Device Registration
Fluid Management Monitoring System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000437_ea9b1d499fa57894478e83232688b715_85c453267af9c555a7b2e4388b2a2a2f. The license holder is Baxter India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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License Holder
Baxter India Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The Starling with NIBP and SpO2 functionalities is a portable, hemodynamic monitoring noninvasive Cardiac Output monitoring device that monitors and displays a patient's Cardiac Output ##PLACEHOLDER_0## in Ltr/Min with a Non-Invasive Blood Pressure ##PLACEHOLDER_0## function that non-invasively measures and displays blood pressure ##PLACEHOLDER_0## and heart rate and with a SpO2 function that non-invasively measures and displays blood oxygen saturation ##PLACEHOLDER_0##. The device displays associated hemodynamic parameters based on measurements or calculations of measurements already incorporated into the Starling. These parameters are: Cardiac Index ##PLACEHOLDER_0##, Stroke Volume ##PLACEHOLDER_0##, Stroke Volume Index ##PLACEHOLDER_0##, Stroke Volume Variation ##PLACEHOLDER_0## Heart Rate ##PLACEHOLDER_0##, Ventricular Ejection Time ##PLACEHOLDER_0##, Total Peripheral Resistance ##PLACEHOLDER_0##, Total Peripheral Resistance Index ##PLACEHOLDER_0##, Cardiac Power ##PLACEHOLDER_0##, Cardiac Power Index ##PLACEHOLDER_0##, Blood Oxygenation ##PLACEHOLDER_0##, Oxygen Delivery Index ##PLACEHOLDER_0##, Electrical impedance of the chest cavity ##PLACEHOLDER_0##, Thoracic Fluid Content ##PLACEHOLDER_0##, Thoracic Fluid Content change from preset time period ##PLACEHOLDER_0##, Thoracic Fluid Content from baseline ##PLACEHOLDER_0##, Changes in SV, CO and other hemodynamic parameters which are derived by Bioreactance
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