DEVICE: CAPIOX® SP PUMP (04987350734433)

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Device Identifier (DI) Information

CAPIOX® SP PUMP
XX*SP03
XX*SP03
TERUMO CORPORATION
04987350734433
GS1
1
SP PUMP HEAD ADAPTER
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
Centrifugal circulatory assist pump, electric A mains electricity (AC-powered), specially constructed, centrifugal pump that is used to maintain blood circulation in heart failure. It is used to provide circulatory assistance (support of the blood circulation when the heart fails) to the patient due to his/her dependence upon artificial assistance in order to maintain the body's heart function. This dependence will be due to the lack of the heart's ability to function normally. The pump may be used during open heart surgery and postoperatively for a short period to assist the heart in regaining function.
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FDA Product Code

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Product Code Product Code Name
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
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Sterilization

No
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: Keep dry. Keep away from sunlight.
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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
June 17, 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
54987350734438 10 04987350734433 In Commercial Distribution Carton
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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
Yes
No
No
No CLOSE

Customer Contact

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