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AMICUS Exchange Kit - Therapeutics

FDA UDI

Class U (US FDA UDI)

by Fresenius Kabi

Identity

Trade Name
AMICUS Exchange Kit - Therapeutics FDA UDI
Generic Name
Therapeutic plasma/red blood cell exchange tubing set FDA UDI
Device Name
For Therapeutic Plasma Exchange (TPE) Procedure. For Red Blood Cell Exchange (RBCX) Procedures. For Use with the AMICUS Separator. Sterile Fluid Path. FDA UDI
Model / Reference
X6R2349 FDA UDI
Description
For Therapeutic Plasma Exchange (TPE) Procedure. For Red Blood Cell Exchange (RBCX) Procedures. For Use with the AMICUS Separator. Sterile Fluid Path. FDA UDI

Identifiers

Catalog Number
X6R2349 FDA UDI
Primary DI / UDI-DI
04086000101950 FDA UDI
510(k) Number
K180615 FDA UDI
FDA Product Code
LKN FDA UDI
GMDN Term
Therapeutic plasma/red blood cell exchange tubing 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Therapeutic plasma/red blood cell exchange tubing set

AMICUS Exchange Kit - Therapeutics by Fresenius Kabi — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Therapeutic plasma/red blood cell exchange tubing set.

Cleared under the same submission

K180615 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fresenius Kabi

Sources (1)

  • FDA UDI d414ac03-5718-4198-87f8-5d080b5c99f2 36 fields · synced Jun 6, 2026