SULFLUX

Primary DI
04537693900639
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® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma.Indications for FSGS:The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
Published
2014-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MMYLipoprotein, Low Density, Removal
PBNApheresis For Focal Glomerulosclerosis In Pediatric Patients

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMYLipoprotein, Low Density, RemovalUnknown3
PBNApheresis For Focal Glomerulosclerosis In Adult And Pediatric PatientsUnknownf

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14537693900636PackageGS16In Commercial Distribution
04537693900639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1453769390063614537693900636
04537693900639045376939006394537693900639

GMDN Terms#

Term, Definition table
TermDefinition
Apheresis system filter, whole bloodA 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
TypeLowHighCondition
Special Storage Condition, Specify00In 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 Temperature0 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8005263521info@liposorber.com

Regulatory Flags#

DUNS number
136605362
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18855036012850TUBING SYSTEM FOR PLASMAPHERESISNK-M3R(U)2015-02-09
18855036020688TUBING SYSTEM FOR PLASMAPHERESISNK-M3R(UL)2018-08-21
14537693900636SULFLUXKP-052014-12-17
04987671040374APHERESIS MACHINEKANEKA MA-032014-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18855036020688TUBING SYSTEM FOR PLASMAPHERESISKANEKA PHARMA AMERICA LLCMMY2018-08-21
18855036020688TUBING SYSTEM FOR PLASMAPHERESISKANEKA PHARMA AMERICA LLCPBN2018-08-21
04046963711139B.BRAUNB.Braun Avitum AGMMY2017-01-20
04046963845773B.BRAUNB.Braun Avitum AGMMY2017-01-20
04046964249679B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963711153B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963711160B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963711177B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963845766B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963845780B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963847418B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964133534B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964231834B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963711184B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964290138B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964290145B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964290152B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964290169B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964319860B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963845797B.BRAUNB.Braun Avitum AGMMY2017-01-17
04046964156731H.E.L.P.®B.Braun Avitum AGMMY2016-03-09
04046964695865H.E.L.P.®B.Braun Avitum AGMMY2016-03-09
04046964696770H.E.L.P.®B.Braun Avitum AGMMY2016-03-09
04046964699467H.E.L.P.®B.Braun Avitum AGMMY2016-03-09
18855036012850TUBING SYSTEM FOR PLASMAPHERESISKANEKA PHARMA AMERICA LLCPBN2015-02-09
18855036012850TUBING SYSTEM FOR PLASMAPHERESISKANEKA PHARMA AMERICA LLCMMY2015-02-09
14537693900636SULFLUXKANEKA PHARMA AMERICA LLCPBN2014-12-17
14993478010110LIPOSORBERKANEKA CORPORATIONPBN2014-09-26
14993478010110LIPOSORBERKANEKA CORPORATIONMMY2014-09-26
24993478010117LIPOSORBERKANEKA CORPORATIONPBN2014-09-26