Duns Number:136605362
Device Description: Indications for FH:The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposab 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).
Catalog Number
-
Brand Name
TUBING SYSTEM FOR PLASMAPHERESIS
Version/Model Number
NK-M3R(UL)
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MMY
Product Code Name
Lipoprotein, Low Density, Removal
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
Package DI Number
28855036020685
Quantity per Package
6
Contains DI Package
18855036020688
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 2 |