Home GUDID 14537693900636 SULFLUX
Primary DI 14537693900636
Brand SULFLUX
Company KANEKA PHARMA AMERICA LLC
Model KP-05
Device description Indications for FH: The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® L
Published 2014-12-17
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name PBN Apheresis For Focal Glomerulosclerosis In Pediatric Patients
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PBN Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients Unknown f
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 14537693900636 Package GS1 6 In Commercial Distribution 04537693900639 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14537693900636 14537693900636 04537693900639 04537693900639 4537693900639
GMDN Terms# Term, Definition table Term 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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 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 0 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 136605362 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 18855036012850 TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(U) 2015-02-09 18855036020688 TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) 2018-08-21 04537693900639 SULFLUX KP-05 2014-12-17 04987671040374 APHERESIS MACHINE KANEKA MA-03 2014-09-25
Other Devices Sharing Product Codes# 
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