Enbrel 25 mg/vial Multiple-use Vial

FDA UDI

Class II (US FDA UDI)

by Amgen Inc.

Identity

Trade Name: Enbrel 25 mg/vial Multiple-use Vial FDA UDI
Generic Name: Medication transfer set FDA UDI
Device Name: Carton contents (4 dose trays, 1 package insert with attached Medication Guide and mixing date stickers) are intended to be dispensed as a unit. Each dose tray contains one 25 mg vial of etanercept, one diluent syringe (1 mL Sterile Bacteriostatic Water for Injection, USP, containing 0.9% benzyl alcohol), one 27 gauge 1/2 inch needle, one vial adapter, and one plunger. FDA UDI
Model / Reference: 642534 FDA UDI
Description: Carton contents (4 dose trays, 1 package insert with attached Medication Guide and mixing date stickers) are intended to be dispensed as a unit. Each dose tray contains one 25 mg vial of etanercept, one diluent syringe (1 mL Sterile Bacteriostatic Water for Injection, USP, containing 0.9% benzyl alcohol), one 27 gauge 1/2 inch needle, one vial adapter, and one plunger. FDA UDI

Identifiers

Primary DI / UDI-DI: 00358406425348 FDA UDI
FDA Product Code: ONB FDA UDI
FMF FDA UDI
GMDN Term: Medication transfer set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5440 FDA UDI
880.5860 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

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 0.5 Inch FDA UDI
Needle Gauge — 27 Gauge FDA UDI

Category: Medication transfer set

Enbrel 25 mg/vial Multiple-use Vial by Amgen Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Amgen Inc.

Sources (1)

FDA UDI adee0cb6-04c9-4be6-a760-406a195ca6e1 35 fields · synced May 29, 2026