Aurora Plasmapheresis System

FDA UDI

Class II (US FDA UDI)

by Fresenius Kabi

Identity

Trade Name: Aurora Plasmapheresis System FDA UDI
Generic Name: Apheresis system FDA UDI
Device Name: Automated plasmapheresis system designed to collect virtually cell-free plasma by membrane filtration using single-use disposable sets. Collected plasma is to be processed as Source Plasma. FDA UDI
Model / Reference: 6R4601 FDA UDI
Description: Automated plasmapheresis system designed to collect virtually cell-free plasma by membrane filtration using single-use disposable sets. Collected plasma is to be processed as Source Plasma. FDA UDI

Identifiers

Catalog Number: 6R4601 FDA UDI
Primary DI / UDI-DI: 04086000100236 FDA UDI
FDA Product Code: GKT FDA UDI
GMDN Term: Apheresis system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.9245 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

Yes

FDA UDI

Category: Apheresis system

Aurora Plasmapheresis System by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

BK110072 also covers:

Fenwal PLASMACELL-C Disposable Set For Use With SPIKESMART System — Fresenius Kabi

BK160012 also covers:

Aurora Software Version 1.3 Upgrade Kit — Fresenius Kabi

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 II	Pending data

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Manufacturer

Manufacturer: Fresenius Kabi

Sources (1)

FDA UDI 2b41ab1c-ca0c-4d6d-8c55-54eb29e3c6cd 35 fields · synced May 30, 2026