Fenwal AMICUS Apheresis Kit- SingleNeedle w/Platelet Additive Solution Connector

FDA UDI

Class II (US FDA UDI)

by Fresenius Kabi

Identity

Trade Name: Fenwal AMICUS Apheresis Kit- SingleNeedle w/Platelet Additive Solution Connector FDA UDI
Generic Name: Apheresis system tubing set FDA UDI
Device Name: For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path. FDA UDI
Model / Reference: 4R2337 FDA UDI
Description: For Extended Platelet Storage with Plasma and Red Blood Cell Collection. 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: 4R2337 FDA UDI
Primary DI / UDI-DI: 04086000101318 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

Fenwal AMICUS Apheresis Kit- SingleNeedle w/Platelet Additive Solution Connector by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID

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Cleared under the same submission

BK090065 also covers:

Fenwal AMICUS Apheresis Kit-Double Needle w/Platelet Additive Solution Connector — Fresenius Kabi

BK120082 also covers:

Fenwal AMICUS Apheresis Kit-Double Needle w/Platelet Additive Solution Connector — Fresenius Kabi

BK150242 also covers:

BK160112 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 552732fc-4938-43e2-a325-dc61a9c7f89a 36 fields · synced May 30, 2026