DEVICE: Heater-Cooler System (04033817900528)

Device Identifier (DI) Information

Heater-Cooler System
3T 120V ~ / 60Hz
In Commercial Distribution

LivaNova Deutschland GmbH
04033817900528
GS1

1
343225272 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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 water (the medium used to regulate the blood temperature), pumps to provide circulation of the water 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

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Product Code Product Code Name
DWC Controller, temperature, cardiopulmonary bypass
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

477104a4-c232-4bb1-b5d7-743249b05cd6
March 29, 2018
2
October 14, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Issuing Agency [?] Secondary DI Number
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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