AccessGUDID - DEVICE: TUBING SYSTEM FOR PLASMAPHERESIS (18855036020688)

GUDID

Device Identifier (DI) Information

Brand Name: TUBING SYSTEM FOR PLASMAPHERESIS
Version or Model: NK-M3R(UL)
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KANEKA PHARMA AMERICA LLC

Primary DI Number: 18855036020688
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 136605362 *Terms of Use

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

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PBN	Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients
MMY	Lipoprotein, Low Density, Removal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 the disposable, handle with care and store in a clean and secure area, 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: 083f36ab-173d-4a6d-9fde-027d3b86beb9
Public Version Date: September 21, 2018
Public Version Number: 1
DI Record Publish Date: August 21, 2018