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Cardiopulmonary bypass temperature controller (Heater-Cooler System 3T 220 V - 50V ) - India CDSCO Medical Device Registration

Cardiopulmonary bypass temperature controller (Heater-Cooler System 3T 220 V - 50V ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000715_b47147f12a88c7171d112dee5a935ad3_8e67bf776a620fa2585748ed4387ece6. This device is marketed under the brand name Stockert S5 Heart Lung Machine. The license holder is LIVANOVA INDIA PVT. LTD., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Cardiopulmonary bypass temperature controller (Heater-Cooler System 3T 220 V - 50V )
UID: IMP/MD/2022/000715_b47147f12a88c7171d112dee5a935ad3_8e67bf776a620fa2585748ed4387ece6

Brand Name

Stockert S5 Heart Lung Machine

Device Class

Class C

Approving Authority

CDSCO

Product Information

Intended Use; The heater-cooler is used with a Stรถckert/Sorin Heart-Lung Machine (Stockert S5 Heart Lung Machine) for the controlled heating/ cooling of 3 water circuits during extracorporeal perfusion. The water circuits are used for cooling/heating blood (Stockert S5 Heart Lung Machine), hypothermia blankets or cardioplegic solutions. Indication for use: The Heater-Cooler System 3T is used to circulate water through heat exchangers to warm or cool a patient undergoing surgical procedures requiring cardiopulmonary bypass

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