Waste Transfer Set

FDA UDI

Class U (US FDA UDI)

by Fresenius Kabi

Identity

Trade Name: Waste Transfer Set FDA UDI
Generic Name: Blood transfer set FDA UDI
Device Name: For Red Blood Cell Exchange (RBCX) Procedures. For use with the AMICUS Separator. Sterile Fluid Path. FDA UDI
Model / Reference: X6C2172 FDA UDI
Description: For Red Blood Cell Exchange (RBCX) Procedures. For use with the AMICUS Separator. Sterile Fluid Path. FDA UDI

Identifiers

Catalog Number: X6C2172 FDA UDI
Primary DI / UDI-DI: 04052682031724 FDA UDI
510(k) Number: K180615 FDA UDI
FDA Product Code: LKN FDA UDI
GMDN Term: Blood transfer set FDA UDI

Classification

Device Class: U 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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Blood transfer set

Waste Transfer Set by Fresenius Kabi — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K180615 also covers:

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 0c40972d-bb1c-4e11-9bfc-e56bc3a6cd6e 36 fields · synced May 29, 2026