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Enbrel 25 mg/vial Replacement

FDA UDI

Class II (US FDA UDI)

by Amgen Inc.

Identity

Trade Name
Enbrel 25 mg/vial Replacement FDA UDI
Generic Name
Medication transfer set FDA UDI
Device Name
Each single-dose vial contains 25 mg (0.5 mL) of Enbrel. FDA UDI
Model / Reference
642591 FDA UDI
Description
Each single-dose vial contains 25 mg (0.5 mL) of Enbrel. FDA UDI

Identifiers

Primary DI / UDI-DI
00358406425911 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

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 Replacement by Amgen Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medication transfer set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Amgen Inc.

Sources (1)

  • FDA UDI 4f5c5b29-5911-48a1-bade-1b28d462c924 35 fields · synced May 30, 2026