Kids Extracorporeal Membrane Oxygenator(Dideco Kids / Sorin Kids Oxygenators) - India CDSCO Medical Device Registration

Kids Extracorporeal Membrane Oxygenator(Dideco Kids / Sorin Kids Oxygenators) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000439_8932d74f43962616ba2175eace158b26_b2fceb8b7880acf1108be81bb33a18fe. This device is marketed under the brand name DHF- Haemoconcentrator. 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

Kids Extracorporeal Membrane Oxygenator(Dideco Kids / Sorin Kids Oxygenators)

UID: IMP/MD/2018/000439_8932d74f43962616ba2175eace158b26_b2fceb8b7880acf1108be81bb33a18fe

Brand Name

DHF- Haemoconcentrator

License Holder

LIVANOVA INDIA PVT. LTD.

Device Class

Class C

Approving Authority

CDSCO

Product Information

050531: It is intended for use in infants who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 0.7 liters/minute. It provides oxygenation and carbon dioxide removal from venous or suctioned blood The Kids Oxygenator should not be used longer than 6 hours. 050540: It is intended for use in infants who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 2.5 liters/minute. It provides oxygenation and carbon dioxide removal from venous or suctioned blood The Kids Oxygenator should not be used longer than 6 hours

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Cardiopulmonary bypass system filter, arterial blood line

Brand: DHF- Haemoconcentrator

LIVANOVA INDIA PVT. LTD.

Kids Extracorporeal Membrane Oxygenator(Dideco Kids / Sorin Kids Oxygenators) - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Cardiopulmonary bypass system filter, arterial blood line

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