DEVICE: QUADROX-i (04037691906942)

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Device Identifier (DI) Information

QUADROX-i
Adult, reservoir
70106.4564
Maquet Cardiopulmonary AG
04037691906942
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

[?]

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

GMDN Preferred Term Name GMDN Definition
Cardiotomy reservoir A device used to collect, store, and filter blood in an extracorporeal circuit during a cardiotomy procedure, typically a cardiopulmonary bypass procedure, trapping micro-particles and air bubbles for a period of time (e.g., 6 hours). It is typically a hardshell or soft, bag-like container with connectors and holds a reserve supply of blood for use in an extracorporeal circuit; some types may also defoam. It may also be used with other devices employed during short-term extracorporeal circulation or used postoperatively as a drainage and autotransfusion reservoir (e.g., for chest drainage) to return autologous blood shed for volume replacement. This is a sterile, single-use device.
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FDA Product Code

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Product Code Product Code Name
DTN RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
DTP Defoamer, cardiopulmonary bypass
JOD FILTER, BLOOD, CARDIOTOMY SUCTION LINE, 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
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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