DEVICE: NA (04037692009932)

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Device Identifier (DI) Information

NA
QUADROX-iD Adult, BIOLINE Coating
70106.7859
Maquet Cardiopulmonary AG
04037692009932
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
Yes
No

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
Extracorporeal membrane oxygenator A device designed for the extracorporeal diffusion of oxygen into the blood across a gas-permeable membrane used mainly during long-term surgery involving heart-lung bypass systems. It includes a membrane made of microporous polypropylene that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The hollow-fibre membrane oxygenator is the most common design and uses thousands of polypropylene or polyethylene (PE) capillary tubes to provide the blood/gas barrier. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DTM Filter, blood, cardiopulmonary bypass, arterial line
DTZ OXYGENATOR, CARDIOPULMONARY BYPASS
DTR HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
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Sterilization

Yes
No
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
Total Volume: 215 Milliliter
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Device Status

Not in Commercial Distribution
December 15, 2015
February 16, 2017
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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
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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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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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+49072229320
info.cp@maquet.com
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