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Sensors - India CDSCO Medical Device Registration

Sensors is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000621_af29aa178ae43211319e28f627e96590_d2f51521fe77b65654febbb37a1d8643. This device is marketed under the brand name Starling. 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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CDSCO Registered
Class Class B
Sensors
UID: IMP/MD/2022/000621_af29aa178ae43211319e28f627e96590_d2f51521fe77b65654febbb37a1d8643

Brand Name

Starling

Device Class

Class B

Approving Authority

CDSCO

Product Information

Indications for Use The Starling monitor with NIBP and SpO2 functionalities is a portable, hemodynamic monitoring non-invasive Cardiac Output monitoring device that monitors and displays a patientโ€™s Cardiac Output (Starling) in Ltr/Min with a Non-Invasive Blood Pressure (Starling) function that non-invasively measures and displays blood pressure (Starling) and heart rate, and with a SpO2 function that non-invasively measures and displays blood oxygen saturation (Starling). The device displays associated hemodynamic parameters based on measurements or calculations of measurements already incorporated into the Starling monitor. These parameters are: โ€ข Cardiac Index (Starling) โ€ข Stroke Volume (Starling) โ€ข Stroke Volume Index (Starling) โ€ข Stroke Volume Variation (Starling) โ€ข Heart Rate (Starling) โ€ข Ventricular Ejection Time (Starling) โ€ข Total Peripheral Resistance (Starling) โ€ข Total Peripheral Resistance Index (Starling) โ€ข Cardiac Power (Starling) โ€ข Cardiac Power Index (Starling) โ€ข Blood Oxygenation (Starling) โ€ข Oxygen Delivery Index (Starling) โ€ข Electrical impedance of the chest cavity (Starling) โ€ข Thoracic Fluid Content (Starling) โ€ข Thoracic Fluid Content change from preset time period (Starling) โ€ข Thoracic Fluid Content from baseline (Starling) โ€ข Changes in SV, CO and other hemodynamic parameters which are derived by Bioreactance.

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