Com.tec

FDA UDI

Class U (US FDA UDI)

by Fresenius Kabi

Identity

Trade Name: COM.TEC FDA UDI
Generic Name: Apheresis system FDA UDI
Device Name: The COM.TEC Blood Cell Separator is a blood cell separator which utilizes centrifugal force as the basis for operation. The fields of application are as follows: - Plasma exchange - Plasma treatment FDA UDI
Model / Reference: 9008031 FDA UDI
Description: The COM.TEC Blood Cell Separator is a blood cell separator which utilizes centrifugal force as the basis for operation. The fields of application are as follows: - Plasma exchange - Plasma treatment FDA UDI

Identifiers

Catalog Number: 9008031 FDA UDI
Primary DI / UDI-DI: 04086000860154 FDA UDI
510(k) Number: K060734 FDA UDI
FDA Product Code: LKN FDA UDI
GMDN Term: Apheresis system FDA UDI

Classification

Device Class: U 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

Com.tec by Fresenius Kabi — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K060734 also covers:

TPE Plasma Exchange Set — 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 U	Pending data

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Manufacturer

Manufacturer: Fresenius Kabi

Sources (1)

FDA UDI 93626510-b09e-4cd8-a8cc-58df845ce1dd 36 fields · synced May 30, 2026