KANEKA PHARMA AMERICA LLC

Address:623 Fifth Avenue,New York,NY,10022,US

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Device Description : Indications for FH:The SULFLUX KP-05 Plasma Separator is one of three disposable Indications for FH:The SULFLUX KP-05 Plasma Separator 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 SULFLUX KP-05 Plasma Separator 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 Class : 3

Duns Number: 136605362

Premarket Exempt : No

Product Code : PBN, MMY

Prescription Use : Yes

Device Count : 1

Device Description : Indications for FH:The Apheresis Machine KANEKA MA-03 is components of the LIPOS Indications for FH:The Apheresis Machine KANEKA MA-03 is 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 Apheresis Machine KANEKA MA-03 is 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 Class : 3

Duns Number: 136605362

Premarket Exempt : No

Product Code : PBN, MMY

Prescription Use : Yes

Device Count : 1

Device Description : Indications for FH:The Tubing System for Plasmapheresis NK-M3R(U) is one of thre 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 Class :

Duns Number: 136605362

Premarket Exempt : No

Product Code : PBN, MMY

Prescription Use : Yes

Device Count : 1

Device Description : Indications for FH:The Tubing System for Plasmapheresis NK-M3R(U) is one of thre 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 Class :

Duns Number: 136605362

Premarket Exempt : No

Product Code : PBN, MMY

Prescription Use : Yes

Device Count : 1