DEVICE: Blood Component Filter Set with Vented Spike and Luer Adapter (04086000100168)

Device Identifier (DI) Information

Blood Component Filter Set with Vented Spike and Luer Adapter
X6C2170
In Commercial Distribution
X6C2170
Fresenius Kabi AG
04086000100168
GS1

1
315654579 *Terms of Use
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
Blood transfusion set A sterile, intravascular administration set used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. 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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K111702 000
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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 Record Status

14ff038d-c39c-48be-8987-ead1cc6319a6
July 06, 2018
3
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
14086000100165 48 04086000100168 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)

[?]
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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