DEVICE: AMICUS Exchange Kit (04086000100151)

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Device Identifier (DI) Information

AMICUS Exchange Kit
X6R2339
X6R2339
Fresenius Kabi AG
04086000100151
GS1
1
For Therapeutic Plasma Exchange (TPE) Procedure. For Use with the AMICUS Separator. Sterile Fluid Path.
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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
Therapeutic plasma/red blood cell exchange tubing set A disposable collection of devices intended to be used in a therapeutic plasma exchange (TPE) or red blood cell exchange system. It typically consists of tubing, solution lines, connection ports, a filter membrane and collection containers (bags) to channel blood from the patient through the extracorporeal circuit to remove a disease-mediating blood component. The blood is returned to the patient with any substitution products. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
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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: Store at Room Temperature. Protect from freezing. Avoid excessive heat.
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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 05, 2016

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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
14086000100158 6 04086000100151 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
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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