DEVICE: Heater-Cooler System (04033817900528)
Device Identifier (DI) Information
Heater-Cooler System
3T 120V ~ / 60Hz
In Commercial Distribution
LivaNova Deutschland GmbH
3T 120V ~ / 60Hz
In Commercial Distribution
LivaNova Deutschland GmbH
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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17206 | Cardiopulmonary bypass system heating/cooling unit |
A mains electricity (AC-powered) component of a cardiopulmonary bypass system designed to heat or cool a patient's body by extracorporeal heat exchange with the patient's perfused blood during a cardiopulmonary bypass procedure. It consists of a system to heat or cool a thermal transfer fluid, pumps to provide circulation of the fluid to a heat exchanger, and monitoring and alarm systems. It may be known as a hypothermia/hyperthermia unit because of its ability to regulate body temperature either way.
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FDA Product Code
[?]Product Code | Product Code Name |
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DWC | Controller, temperature, cardiopulmonary bypass |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K052601 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
477104a4-c232-4bb1-b5d7-743249b05cd6
December 23, 2019
5
October 14, 2015
December 23, 2019
5
October 14, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined