DEVICE: SULFLUX (04537693900639)

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Device Identifier (DI) Information

SULFLUX
KP-05

KANEKA PHARMA AMERICA LLC
04537693900639
GS1
1
The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER LA-15 System.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
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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
Apheresis system filter, whole blood A sterile device designed to separate plasma from the cellular components of whole blood during manual/automated apheresis (the separation, collection, and reinfusion of blood) for donation of blood products or apheresis therapy. It typically contains a microporous membrane (usually with pores 0.2 to 0.6 micrometers) or a hollow-fibre column; it may also be intended to filter microorganisms and/or particles. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
MMY Lipoprotein, Low Density, Removal
PBN Apheresis For Focal Glomerulosclerosis In Pediatric Patients
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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: In transporting and storing the Plasma Separator, handle with care. Store in a clean and secure area, avoiding exposure to direct sunlight, high humidity or excessive vibration.
Storage Environment Temperature: between 0 and 30 Degrees Celsius
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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
December 17, 2014

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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
14537693900636 6 04537693900639 In Commercial Distribution Outer 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

[?]
8005263521
info@liposorber.com
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