CDSCO UID IMP/MD/2022/000715_b47147f12a88c7171d112dee5a935ad3_8e67bf776a620fa2585748ed4387ece6
Cardiopulmonary bypass temperature controller (Heater-Cooler System 3T 220 V - 50V )
LIVANOVA INDIA PVT. LTD.·Device Class Class C·India CDSCO·Brand: Stockert S5 Heart Lung Machine
Registration details
- UID
- IMP/MD/2022/000715_b47147f12a88c7171d112dee5a935ad3_8e67bf776a620fa2585748ed4387ece6
- Device class
- Class C
- Brand name
- Stockert S5 Heart Lung Machine
- License holder
- LIVANOVA INDIA PVT. LTD.
- Approving authority
- CDSCO
- Product information
- Intended Use; The heater-cooler is used with a Stöckert/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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About this record
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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