DEVICE: CAPIOX® HEMOCONCENTRATOR (04987350738356)

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Device Identifier (DI) Information

CAPIOX® HEMOCONCENTRATOR
CX*HC05L

TERUMO CORPORATION
04987350738356
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
Haemoconcentrator A sterile filter intended to be used in the process of haemoconcentration (the concentration of blood elements by water and electrolyte removal) typically during treatment for fluid overload or during cardiac surgery involving extracorporeal circulation. It is typically an ultrafiltration filter contained within a closed cylindrical housing with connectors to an extracorporeal blood circuit and separate connectors for the removal of excess plasma water together with small plasma solutes (e.g., smaller than 50,000 Daltons); the haemoconcentrate is returned to the patient. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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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
Area/Surface Area: 0.5 Square meter
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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
54987350738351 10 04987350738356 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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