DEVICE: CAPIOX® VENOUS RESERVOIR (04987350706591)

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Device Identifier (DI) Information

CAPIOX® VENOUS RESERVOIR
CX*VRA0701T2

TERUMO CORPORATION
04987350706591
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
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
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
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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
Special Storage Condition, Specify: Fragile. This way up. Keep away from sunlight. Keep away from rain.
Handling Environment Temperature: between 1 and 40 Degrees Celsius
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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
September 15, 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
34987350706592 4 04987350706591 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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1-800-521-2818
cvscustomerservice@terumomedical.com
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