Home GUDID 00358406425911 Enbrel 25 mg/vial Replacement
Primary DI 00358406425911
Brand Enbrel 25 mg/vial Replacement
Company AMGEN INC.
Model 642591
Device description Each single-dose vial contains 25 mg (0.5 mL) of Enbrel.
Published 2021-12-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name FMF Syringe, Piston ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FMF Syringe, Piston General Hospital 2 ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10358406425918 Package GS1 16 In Commercial Distribution 00358406425911 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10358406425918 10358406425918 00358406425911 00358406425911 358406425911 0358406425911
GMDN Terms# Term, Definition table Term Definition Medication transfer set A collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 0.5 Inch Needle Gauge 27 Gauge
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Do not freeze or store in extreme heat or cold. Special Storage Condition, Specify 0 0 Do not shake Special Storage Condition, Specify 0 0 Keep Enbrel out of the reach of children Special Storage Condition, Specify 0 0 Store Enbrel in the original carton to protect from light or damage. Special Storage Condition, Specify 0 0 Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C). Special Storage Condition, Specify 0 0 Store the Enbrel single-dose vials at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days. Throw away Enbrel that has been stored at room temperature after 14 days.
Regulatory Flags# DUNS number 039976196 Device count 1 DM exempt true Kit true Combination product true Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 09347144013062 Metier Medical METIER MEDICAL LTD FMF 2026-10-19 09347144013123 Metier Medical METIER MEDICAL LTD FMF 2026-10-19 09347144015004 Metier Medical METIER MEDICAL LTD FMF 2026-10-12 09347144016186 Metier Medical METIER MEDICAL LTD FMF 2026-10-12 09347144016216 Metier Medical METIER MEDICAL LTD FMF 2026-10-12 20612479288496 McKesson MCKESSON MEDICAL-SURGICAL INC. FMF 2026-10-08 20612479288526 McKesson MCKESSON MEDICAL-SURGICAL INC. FMF 2026-10-08 10304040193843 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193850 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193867 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193874 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193881 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193898 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194109 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194116 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194208 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194215 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194222 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194239 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194246 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194253 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194260 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194277 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194284 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194291 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194307 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194314 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 05391530753982 polycarbonate syringes DMC MEDICAL LIMITED FMF 2026-10-01 05391530753999 polycarbonate syringes DMC MEDICAL LIMITED FMF 2026-10-01 05391530754408 polycarbonate syringes DMC MEDICAL LIMITED FMF 2026-10-01