Enbrel 25 mg/vial Multiple-use Vial

GUDID 10358406425345

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.

AMGEN INC.

Medication transfer set

• Primary Device ID: 10358406425345
• NIH Device Record Key: adee0cb6-04c9-4be6-a760-406a195ca6e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enbrel 25 mg/vial Multiple-use Vial
• Version Model Number: 642534
• Company DUNS: 039976196
• Company Name: AMGEN INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Needle Gauge: 27 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00358406425348 [Primary]
GS1	10358406425345 [Package]; Contains: 00358406425348; Package: Case [8 Units]; In Commercial Distribution

FDA Product Code

• ONB: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-01
• Device Publish Date: 2019-10-24

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