Fresenius Kabi Apheresis Needle with masterguard Anti-Stick Needle Protector

FDA UDI

Class II (US FDA UDI)

by NxStage Medical, Inc.

Identity

Trade Name: Fresenius Kabi Apheresis Needle with masterguard Anti-Stick Needle Protector FDA UDI
Generic Name: Non-fixed blood collection needle FDA UDI
Model / Reference: 4R2440 FDA UDI

Identifiers

Primary DI / UDI-DI: 00842289102620 FDA UDI
FDA Product Code: FIE FDA UDI
GMDN Term: Non-fixed blood collection needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5540 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

Dimensions & Sizes

Size: Needle Gauge — 16 Gauge FDA UDI
Length — 1.25 Inch FDA UDI

Category: Non-fixed blood collection needle

Fresenius Kabi Apheresis Needle with masterguard Anti-Stick Needle Protector by NxStage Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID

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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: NxStage Medical, Inc.

Sources (1)

FDA UDI e717de78-e780-458e-9e86-063bf9396899 35 fields · synced Jun 9, 2026