AccessGUDID - DEVICE: LIPOSORBER (14993478010110)

GUDID

Device Identifier (DI) Information

Brand Name: LIPOSORBER
Version or Model: LA-15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: KANEKA CORPORATION

Primary DI Number: 14993478010110
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 690535406 *Terms of Use

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).

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
PBN	Apheresis For Focal Glomerulosclerosis In Pediatric Patients
MMY	Lipoprotein, Low Density, Removal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H120005	001
P910018	016
P910018	017

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: In 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 Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 097fa2bd-0bf9-4ac6-bf30-45a06efc9fb4
Public Version Date: October 30, 2023
Public Version Number: 6
DI Record Publish Date: September 26, 2014