FDA.reportPublic FDA data

LIPOSORBER

Primary DI
14993478010110
Brand
LIPOSORBER
Company
KANEKA CORPORATION
Model
LA-15
Catalog number
N/A
Device description
Indications for FH: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 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
2014-09-26
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
24993478010117PackageGS16In Commercial Distribution
14993478010110PrimaryGS10
04993478010113Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2499347801011724993478010117
1499347801011014993478010110
04993478010113049934780101134993478010113

GMDN Terms#

Term, Definition table
TermDefinition
Haemoperfusion system absorption columnA sterile container that is a component of a haemoperfusion system used for the removal of toxins from a patient's blood, and that holds materials (e.g., activated carbon or resins) which absorb (adsorb) a specific toxin or range of toxins. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00In transporting and storing, handle with care and store in a clean and secure area at room temperature (5-30°C), avoiding exposure to direct sunlight, high humidity or excessive vibration.
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8005263521info@liposorber.com

Regulatory Flags#

DUNS number
690535406
Device count
2
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14993478010042LIXELLES-35N/A2024-10-25
14993478010059LIXELLES-15N/A2024-10-25
14993478010066LIXELLES-25N/A2024-10-25
04540778177086i-ED COIL392-0615392-06152025-12-10
04540778177116i-ED COIL392-0720392-07202025-12-10
04540778193710i-ED COIL393-020320393-0203202025-12-10
04540778193727i-ED COIL393-020330393-0203302025-12-10
04540778171398LACRIFLOW CLLF-CL090A2017-06-01
04540778171381LACRIFLOW CLLF-CL105A2017-06-01
04540778177031i-ED COIL392-0408392-04082025-06-26
14993478020225Lixelle S-25N/A2015-05-01
14993478020232Lixelle S-35N/A2015-05-01
14993478020218Lixelle S-15N/A2015-05-01
04540778177291i-ED COIL393-030510393-0305102024-10-25
04540778190412i-ED COIL390-0212390-02122024-10-25
04540778190429i-ED COIL393-030530393-0305302024-10-25
24993478010049LIXELLES-35N/A2024-10-25
04993478010052LIXELLES-15N/A2024-10-25
04993478010069LIXELLES-25N/A2024-10-25
04540778176485i-ED COIL390-01H4390-01H42023-07-27

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 LLCMMY2015-02-09
18855036012850TUBING SYSTEM FOR PLASMAPHERESISKANEKA PHARMA AMERICA LLCPBN2015-02-09
04537693900639SULFLUXKANEKA PHARMA AMERICA LLCPBN2014-12-17
04537693900639SULFLUXKANEKA PHARMA AMERICA LLCMMY2014-12-17
14537693900636SULFLUXKANEKA PHARMA AMERICA LLCPBN2014-12-17
24993478010117LIPOSORBERKANEKA CORPORATIONPBN2014-09-26