AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly

FDA UDI

Class II (US FDA UDI)

by Fresenius Kabi

Identity

Trade Name: AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly FDA UDI
Generic Name: Apheresis system tubing set FDA UDI
Device Name: For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path. FDA UDI
Model / Reference: 4R2353G FDA UDI
Description: For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path. FDA UDI

Identifiers

Catalog Number: 4R2353G FDA UDI
Primary DI / UDI-DI: 00810020440164 FDA UDI
FDA Product Code: GKT FDA UDI
GMDN Term: Apheresis system tubing set 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

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: Apheresis system tubing set

AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID

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Cleared under the same submission

BK150357 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 II	Pending data

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Manufacturer

Manufacturer: Fresenius Kabi

Sources (1)

FDA UDI f5a80a37-e92a-448f-85b2-5cfc32d0b095 36 fields · synced May 30, 2026