LIPOSORBER

Basic Information

• Brand Name: LIPOSORBER
• Primary DI: 14993478010110
• Version / Model: LA-15
• Catalog Number: N/A
• Company Name: KANEKA CORPORATION
• Labeler DUNS: 690535406
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2014-09-26
• Public Version: 6
• Public Version Date: 2023-10-30
• Public Version Status: Update
• Public Device Record Key: 097fa2bd-0bf9-4ac6-bf30-45a06efc9fb4

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PBN	Apheresis For Focal Glomerulosclerosis In Pediatric Patients	Unknown		f
MMY	Lipoprotein, Low Density, Removal	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24993478010117	GS1	Carrier Box	6	In Commercial Distribution
Primary	14993478010110	GS1
Unit of Use	04993478010113	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
H120005	001
P910018	016
P910018	017

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: 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.
• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius