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Cardiopulmonary bypass Heat Exchanger - India CDSCO Medical Device Registration

Cardiopulmonary bypass Heat Exchanger is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000439_969ac5464be8752cf37951273b2a0473_46c8ba0dabbee81a5aaf325f7d7ccda3. This device is marketed under the brand name Perfusion Tubing System โ€“ Customized Perfusion Tubing System for Cardiac Surgery 1. IN INDIA STANDARD CARD./ CSC14 , 2. IT MIRANDOLA STANDARD MISC./ASSISTED VENOUS DRAINAGE KIT- , 3. IN INDIA STANDARD CARD./ CSC14 DEL NIDO DESIGN , 4. Perfusion Tubing System - Customized Perfusion Tubing System for Cardiac Surgery . The license holder is LIVANOVA INDIA PVT. LTD., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
Cardiopulmonary bypass Heat Exchanger
UID: IMP/MD/2018/000439_969ac5464be8752cf37951273b2a0473_46c8ba0dabbee81a5aaf325f7d7ccda3

Brand Name

Perfusion Tubing System โ€“ Customized Perfusion Tubing System for Cardiac Surgery 1. IN INDIA STANDARD CARD./ CSC14 , 2. IT MIRANDOLA STANDARD MISC./ASSISTED VENOUS DRAINAGE KIT- , 3. IN INDIA STANDARD CARD./ CSC14 DEL NIDO DESIGN , 4. Perfusion Tubing System - Customized Perfusion Tubing System for Cardiac Surgery

Device Class

Class B

Approving Authority

CDSCO

Product Information

CSC14 is recommended for use as a heating/cooling device and bubble trap for blood cardioplegia and clear fluid perfusion in extracorporeal circulation associated with cardiopulmonary bypass. It is suggested not to use CSC14 for more than 6 hours

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