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Autotransfusion Cell Separator - India CDSCO Medical Device Registration

Autotransfusion Cell Separator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000715_8f63a7521f708c251b110ced72d16460_a096f1447aee33ce6242857ee913c3a6. 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
Autotransfusion Cell Separator
UID: IMP/MD/2022/000715_8f63a7521f708c251b110ced72d16460_a096f1447aee33ce6242857ee913c3a6

Brand Name

Stockert S5 Heart Lung Machine

Device Class

Class C

Approving Authority

CDSCO

Product Information

XTRA is indicated for use for intraoperative recovery of blood, washing of blood collected in the postoperative period and preoperative sequestration (Stockert S5 Heart Lung Machine). More specifically, the XTRA may be used for processing: - Blood shed by a patient during surgery - Blood collected preoperatively from trauma patients (Stockert S5 Heart Lung Machine) - Blood collected postoperatively from chest or wound drains - Blood in the heart-lung bypass circuit either during or after bypass - Blood collected for the purpose of autologous preoperative sequestration

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