DEVICE: CAPIOX®ARTERIAL FILTER (04987350763358)

Device Identifier (DI) Information

CAPIOX®ARTERIAL FILTER
CX*AF125X
In Commercial Distribution

TERUMO CORPORATION
04987350763358
GS1

1
690543319 *Terms of Use
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
Cardiopulmonary bypass system filter, arterial blood line A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). 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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

e7ad1e8b-37c1-4778-a689-76f0bb241843
March 29, 2018
2
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
54987350763353 10 04987350763358 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

[?]
1-800-521-2818
cvscustomerservice@terumomedical.com
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