Thermodilution Catheters(Swan-Ganz True Size Thermodilution Catheter, Swan-Ganz Thermodilution Venous Infusion Port Catheter) - India CDSCO Medical Device Registration

Thermodilution Catheters(Swan-Ganz True Size Thermodilution Catheter, Swan-Ganz Thermodilution Venous Infusion Port Catheter) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000344_dbc6ba80b65277019567001a2ed8a4b9_952d29a7880322f609a2c8c1d34d449b. This device is marketed under the brand name Swan-Ganz CCO, Swan-Ganz CCO V, Swan-Ganz CCOmbo, Swan-Ganz CCOmbo V Thermodilution Catheters. The license holder is Edwards Lifesciences (India) Private Limited,, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Thermodilution Catheters(Swan-Ganz True Size Thermodilution Catheter, Swan-Ganz Thermodilution Venous Infusion Port Catheter)

UID: IMP/MD/2018/000344_dbc6ba80b65277019567001a2ed8a4b9_952d29a7880322f609a2c8c1d34d449b

Brand Name

Swan-Ganz CCO, Swan-Ganz CCO V, Swan-Ganz CCOmbo, Swan-Ganz CCOmbo V Thermodilution Catheters

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class D

Approving Authority

CDSCO

Product Information

Swan Ganz thermodilution catheters are indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (Swan-Ganz CCO, Swan-Ganz CCO V, Swan-Ganz CCOmbo, Swan-Ganz CCOmbo V Thermodilution Catheters) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

Class D

Thermodilution Catheters

Brand: Swan-Ganz CCO, Swan-Ganz CCO V, Swan-Ganz CCOmbo, Swan-Ganz CCOmbo V Thermodilution Catheters

Edwards Lifesciences (India) Private Limited,

Class D

Brand: Fem-Flex II™ Femoral Arterial Cannula

Class D