Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure - India CDSCO Medical Device Registration
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000439_ef4aea8d2e36115cc95dd2f5ff5919b1_752a2a2ce68ad3c523de4a26fc63e80c. This device is marketed under the brand name Perfusion Tubing System – 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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Brand Name
Perfusion Tubing System – 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
License Holder
LIVANOVA INDIA PVT. LTD.Device Class
Approving Authority
CDSCO
Product Information
Intended for use as extracorporeal circuit for patient requiring cardiac, respiratory or full cardiopulmonary support. This device pack is intended for use during surgery requiring cardiopulmonary or other surgical techniques. It is intended for use together with such equipment as blood pumps, centrifugal pump consoles, oxygenators, reservoir, filter, heat exchangers and cannulae. "
Coronary Perfusion Cannulae
Brand: Perfusion Tubing System – 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
LIVANOVA INDIA PVT. LTD.
Coronary Aortic Root Cannulae
Brand: Perfusion Tubing System – 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
LIVANOVA INDIA PVT. LTD.
Cardiopulmonary Bypass Heat System Blood Gas Sensor
Brand: Perfusion Tubing System – 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
LIVANOVA INDIA PVT. LTD.
Cardiopulmonary Bypass System Centrifugal Pump
Brand: Perfusion Tubing System – 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
LIVANOVA INDIA PVT. LTD.
Pediatric Cannulae
Brand: Perfusion Tubing System – 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
LIVANOVA INDIA PVT. LTD.
Cardiopulmonary bypass Heat Exchanger
Brand: Perfusion Tubing System – 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
LIVANOVA INDIA PVT. LTD.
Venous Cannulae
Brand: Perfusion Tubing System – 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
LIVANOVA INDIA PVT. LTD.
Catheter
Brand: Perfusion Tubing System – 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
LIVANOVA INDIA PVT. LTD.
Cannulae
Brand: Perfusion Tubing System – 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
LIVANOVA INDIA PVT. LTD.
Cannulae
Brand: Perfusion Tubing System – 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
LIVANOVA INDIA PVT. LTD.
Cardiopulmonary bypass Heart Lung Machine(Essenz HLM )
Brand: Stockert S5 Heart Lung Machine
Cardiopulmonary bypass Heart Lung Machine(Modular perfusion system : It offers 4 different types S5 Console as follows: 1. S5 console 3 position , 2. S5 console 4 position , 3. S5 console 5 position , 4. CP5 Console )
Brand: Stockert S5 Heart Lung Machine
Software for Perfusion data management systems(Sorin Connect )
Brand: Stockert S5 Heart Lung Machine
Cardiopulmonary bypass temperature controller (Heater-Cooler System 3T 220 V - 50V )
Brand: Stockert S5 Heart Lung Machine
Autotransfusion System
Brand: Stockert S5 Heart Lung Machine
Autotransfusion Cell Separator
Brand: Stockert S5 Heart Lung Machine
Data Management System for Cardiopulmonary Perfusion
Brand: Stockert S5 Heart Lung Machine
Imaging devices utilizing non-ionizing radiation. Medistim MiraQ Cardiac System, 2).Medistim MiraQ Vascular Systems, 3).Medistim MiraQ Ultimate Systems)
Brand: Medistim MiraQ System, available in different configuration as follows: 1
Imaging and volume flowmeter probes
Brand: Medistim TTFM Probes , available in different configuration as follows: 1
Imaging and volume flowmeter probes
Brand: Medistim TTFM Probes , available in different configuration as follows: 1