DEVICE: QUADROX-i (04037691770970)

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Device Identifier (DI) Information

QUADROX-i
Pediatric, filter
70105.5215
Maquet Cardiopulmonary AG
04037691770970
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
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
DTR HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
DTZ OXYGENATOR, 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
No Device Sizes
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Device Status

In Commercial Distribution
October 24, 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
04037691770987 4 04037691770970 In Commercial Distribution
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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