TUBING SYSTEM FOR PLASMAPHERESIS

Primary DI
18855036012850
Brand
TUBING SYSTEM FOR PLASMAPHERESIS
Company
KANEKA PHARMA AMERICA LLC
Model
NK-M3R(U)
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).
Published
2015-02-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MMYLipoprotein, Low Density, Removal
PBNApheresis For Focal Glomerulosclerosis In Pediatric Patients

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMYLipoprotein, Low Density, RemovalUnknown3
PBNApheresis For Focal Glomerulosclerosis In Adult And Pediatric PatientsUnknownf

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28855036012857PackageGS16In Commercial Distribution
18855036012850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2885503601285728855036012857
1885503601285018855036012850

GMDN Terms#

Term, Definition table
TermDefinition
Apheresis system tubing setA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00In 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 Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8005263521info@liposorber.com

Regulatory Flags#

DUNS number
136605362
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18855036020688TUBING SYSTEM FOR PLASMAPHERESISNK-M3R(UL)2018-08-21
04537693900639SULFLUXKP-052014-12-17
14537693900636SULFLUXKP-052014-12-17
04987671040374APHERESIS MACHINEKANEKA MA-032014-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18855036020688TUBING SYSTEM FOR PLASMAPHERESISKANEKA PHARMA AMERICA LLCMMY2018-08-21
18855036020688TUBING SYSTEM FOR PLASMAPHERESISKANEKA PHARMA AMERICA LLCPBN2018-08-21
04046963711139B.BRAUNB.Braun Avitum AGMMY2017-01-20
04046963845773B.BRAUNB.Braun Avitum AGMMY2017-01-20
04046964249679B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963711153B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963711160B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963711177B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963845766B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963845780B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963847418B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964133534B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964231834B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963711184B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964290138B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964290145B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964290152B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964290169B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964319860B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963845797B.BRAUNB.Braun Avitum AGMMY2017-01-17
04046964156731H.E.L.P.®B.Braun Avitum AGMMY2016-03-09
04046964695865H.E.L.P.®B.Braun Avitum AGMMY2016-03-09
04046964696770H.E.L.P.®B.Braun Avitum AGMMY2016-03-09
04046964699467H.E.L.P.®B.Braun Avitum AGMMY2016-03-09
04537693900639SULFLUXKANEKA PHARMA AMERICA LLCPBN2014-12-17
04537693900639SULFLUXKANEKA PHARMA AMERICA LLCMMY2014-12-17
14537693900636SULFLUXKANEKA PHARMA AMERICA LLCPBN2014-12-17
14993478010110LIPOSORBERKANEKA CORPORATIONPBN2014-09-26
14993478010110LIPOSORBERKANEKA CORPORATIONMMY2014-09-26
24993478010117LIPOSORBERKANEKA CORPORATIONPBN2014-09-26