Hemodynamic Monitoring System - India CDSCO Medical Device Registration
Hemodynamic Monitoring System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000135_162e8bca984f1a185bbe400302552cf2_f9b6c70e179cdde359adc159fe5b3e0e. This device is marketed under the brand name FORE-SIGHT ELITEโข Tissue Oximeter Module. The license holder is Edwards Lifesciences (India) Private Limited,, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
FORE-SIGHT ELITEโข Tissue Oximeter Module
License Holder
Edwards Lifesciences (India) Private Limited,Device Class
Approving Authority
CDSCO
Product Information
The noninvasive FORE-SIGHT ELITE module is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the Sensors in individuals at risk for reduced-flow or no-flow ischemic states. The FORE-SIGHT ELITE tissue oximeter module is intended to allow for the display of StO2 on the HemoSphere advanced monitor. โข When used with large sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for use on adults and transitional adolescents โฅ40 kg. โข When used with Medium Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for use on pediatric subjects โฅ3 kg. โข When used with Small Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg
Tissue Oximetry Sensor
Brand: ForeSight Large Sensor
Tissue Oximetry Sensor
Brand: ForeSight Large Sensor
Tissue Oximetry Sensor
Brand: Fore-Sight Elite Large Sensor
Tissue Oximetry Sensor
Brand: ForeSight Large Sensor
Tissue Oximetry Sensor
Brand: Fore-Sight Elite Large Sensor
Tissue Oximetry Sensor
Brand: ForeSight Large Sensor
Tissue Oximetry Sensor
Brand: Fore-Sight Elite Large Sensor
Tissue Oximetry Sensor
Brand: Fore-Sight Elite Large Sensor
Arterial Perfusion Cannula
Brand: Fem-Flex IIโข Femoral Arterial Cannula
Femoral Arterial Cannula
Brand: Fem-Flex IIโข Femoral Arterial Cannula

