AccessGUDID - DEVICE: LIXELLE (14993478010066)

GUDID

Device Identifier (DI) Information

Brand Name: LIXELLE
Version or Model: S-25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: KANEKA CORPORATION

Primary DI Number: 14993478010066
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 690535406 *Terms of Use

Device Description: The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialysis-related amyloidosis (DRA).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34422	Haemoperfusion system absorption column	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PDI	Beta 2-Microglobulin Apheresis Column

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H130001	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Avoid 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 Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e2a2f272-537d-4012-b3dc-30d3f22d0ade
Public Version Date: November 04, 2024
Public Version Number: 1
DI Record Publish Date: October 25, 2024