Lixelle

Primary DI
14993478020225
Brand
Lixelle
Company
KANEKA CORPORATION
Model
S-25
Catalog number
N/A
Device description
The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialysis-related amyloidosis (DRA).
Published
2015-05-01
Public version status
Update
Distribution status
Not 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
PDIBeta 2-Microglobulin Apheresis Column

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDIBeta 2-Microglobulin Apheresis ColumnUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H130001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H130001000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24993478020222PackageGS12Not in Commercial Distribution
14993478020225PrimaryGS10
04993478010069Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2499347802022224993478020222
1499347802022514993478020225
04993478010069049934780100694993478010069

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, Specify00Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps).
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8005263521info@liposorber.com

Regulatory Flags#

DUNS number
690535406
Device count
6
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
14993478010110LIPOSORBERLA-15N/A2014-09-26
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
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
14993478010042LIXELLEKANEKA CORPORATIONPDI2024-10-25
14993478010059LIXELLEKANEKA CORPORATIONPDI2024-10-25
14993478010066LIXELLEKANEKA CORPORATIONPDI2024-10-25
24993478010049LIXELLEKANEKA CORPORATIONPDI2024-10-25
04993478010052LIXELLEKANEKA CORPORATIONPDI2024-10-25
04993478010069LIXELLEKANEKA CORPORATIONPDI2024-10-25
14993478020232Lixelle KANEKA CORPORATIONPDI2015-05-01
14993478020218Lixelle KANEKA CORPORATIONPDI2015-05-01
24993478020222Lixelle KANEKA CORPORATIONPDI2015-05-01
24993478020239Lixelle KANEKA CORPORATIONPDI2015-05-01