Tubing System For Plasmapheresis

FDA UDI

Class Unclassified (US FDA UDI)

by Kaneka Pharma America Corp.

Identity

Trade Name: TUBING SYSTEM FOR PLASMAPHERESIS FDA UDI
Generic Name: Apheresis system tubing set FDA UDI
Device Name: 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). FDA UDI
Model / Reference: NK-M3R(U) FDA UDI
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). FDA UDI

Identifiers

Primary DI / UDI-DI: 18855036012850 FDA UDI
FDA Product Code: PBN FDA UDI
MMY FDA UDI
GMDN Term: Apheresis system tubing set FDA UDI

Classification

Device Class: Unclassified FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Apheresis system tubing set

Tubing System For Plasmapheresis by Kaneka Pharma America Corp. — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class Unclassified	Pending data

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Manufacturer

Manufacturer: Kaneka Pharma America Corp.

Sources (1)

FDA UDI 8fe266be-b16b-4db2-a760-0743ee0376e3 35 fields · synced May 31, 2026