DEVICE: Electrical Remote-Controlled Tubing Clamp (04033817901051)

Device Identifier (DI) Information

Electrical Remote-Controlled Tubing Clamp
500 mm
In Commercial Distribution

LivaNova Deutschland GmbH
04033817901051
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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No
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35099 Cardiopulmonary bypass system, roller type
An assembly of devices that provides mechanical circulatory support during open-heart surgery, bypassing the heart to facilitate surgery on the organ. The basic function of the machine is to oxygenate the body's venous supply of blood and then pump it back into the arterial circuit. It will typically provide intracardiac suction, filtration, and temperature control. This device typically consists of mains electricity (AC-powered) console with roller pumps, oxygenators, a heat exchanger, temperature regulators, a reservoir, filters, a defoamer, and a handcrank for manual emergency rotation of a blood pump. Some systems are manufactured as a single unit while others are made up of modules.
Active false
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FDA Product Code

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Product Code Product Code Name
DTQ CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K071318 000
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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

5991803f-33b1-4383-b3f5-a8a169b1ad57
July 06, 2018
3
October 20, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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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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