Apheresis Machine

FDA UDI

Class Unclassified (US FDA UDI)

by Kaneka Pharma America Corp.

Identity

Trade Name: APHERESIS MACHINE FDA UDI
Generic Name: Apheresis system FDA UDI
Device Name: 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). FDA UDI
Model / Reference: KANEKA MA-03 FDA UDI
Description: 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). FDA UDI

Identifiers

Primary DI / UDI-DI: 04987671040374 FDA UDI
FDA Product Code: PBN FDA UDI
MMY FDA UDI
GMDN Term: Apheresis system FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Apheresis system

Apheresis Machine by Kaneka Pharma America Corp. — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Apheresis system.

Aurora Software Version 1.3 Upgrade Kit — Fresenius Kabi · Class II
Trima Accel® — Terumo BCT, Inc.. · Class II
Aurora Xi Plasmapheresis System — Fresenius Kabi · Class II
Aurora Plasmapheresis System — Fresenius Kabi · Class II
AMICUS Separator Legacy Software — Fresenius Kabi · Class II
Aurora Xi Plasmapheresis System — Fresenius Kabi · Class II
Trima Accel® — Terumo BCT, Inc.. · Class II
Aurora Plasmapheresis System Software Version 2.1 — Fresenius Kabi · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Kaneka Pharma America Corp.

Sources (1)

FDA UDI da239c04-1a04-4389-a543-7e3f31de50b4 35 fields · synced May 30, 2026