LIXELLE

Primary DI
24993478010049
Brand
LIXELLE
Company
KANEKA CORPORATION
Model
S-35
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
2024-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
24993478010049PackageGS12In Commercial Distribution
14993478010042PrimaryGS10
04993478010045Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2499347801004924993478010049
1499347801004214993478010042
04993478010045049934780100454993478010045

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8005263521info@liposorber.com

Regulatory Flags#

DUNS number
690535406
Device count
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 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
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
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
04993478010052LIXELLEKANEKA CORPORATIONPDI2024-10-25
04993478010069LIXELLEKANEKA CORPORATIONPDI2024-10-25
14993478020225Lixelle KANEKA CORPORATIONPDI2015-05-01
14993478020232Lixelle KANEKA CORPORATIONPDI2015-05-01
14993478020218Lixelle KANEKA CORPORATIONPDI2015-05-01
24993478020222Lixelle KANEKA CORPORATIONPDI2015-05-01
24993478020239Lixelle KANEKA CORPORATIONPDI2015-05-01