TUBING SYSTEM FOR PLASMAPHERESIS

Basic Information

• Brand Name: TUBING SYSTEM FOR PLASMAPHERESIS
• Primary DI: 18855036012850
• Version / Model: NK-M3R(U)
• Company Name: KANEKA PHARMA AMERICA LLC
• Labeler DUNS: 136605362
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-02-09
• Public Version: 3
• Public Version Date: 2018-05-29
• Public Version Status: Update
• Public Device Record Key: 8fe266be-b16b-4db2-a760-0743ee0376e3

Device Description

Indications for FH: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. 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 Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. 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
47572	Apheresis system tubing set	A collection of sterile, flexible, plastic tube segments and associated items (e.g., connectors, line clamp, drip chamber) intended to be used in an apheresis system to channel blood from the patient to an appropriate apheresis column before being returned to the patient. It creates a closed-circuit for the extracorporeal removal of a constituent of whole blood (e.g., leukocytes, plasma). The channeling of apheresis solutions for the priming, regeneration, preservation of columns before or after an apheresis procedure may also be through the tubing set. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18855036012850	GS1
Package	28855036012857	GS1	Outer Box	6	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: In transporting and storing the disposable, handle with care and store in a clean and secure area, avoiding exposure to direct sunlight, high humidity or excessive vibration.
• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius