FDA.reportPublic FDA data

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
CodeName
FMFSyringe, Piston
ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10358406425918PackageGS116In Commercial Distribution
00358406425911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035840642591810358406425918
00358406425911003584064259113584064259110358406425911

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer setA 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
TypeValueUnit
Length0.5Inch
Needle Gauge27Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze or store in extreme heat or cold.
Special Storage Condition, Specify00Do not shake
Special Storage Condition, Specify00Keep Enbrel out of the reach of children
Special Storage Condition, Specify00Store Enbrel in the original carton to protect from light or damage.
Special Storage Condition, Specify00Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).
Special Storage Condition, Specify00Store 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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00355513770019Repatha Pushtronex System90028702019-09-24
00355513770910Repatha Pushtronex System, sample90032432021-12-13
00372511770018Repatha Pushtronex System90066552021-12-13
00372511770919Repatha Pushtronex System, sample90081242022-08-24
00358406470010AutoTouch reusable autoinjector90036002019-09-24
00358406480019AutoTouch Connect reusable autoinjector90069402021-11-08
10372511770916Repatha Pushtronex System, sample90081242022-08-24
10355513770917Repatha Pushtronex System, sample90032432021-12-13
10358406425918Enbrel 25 mg/vial Replacement6425912021-12-13
10372511770015Repatha Pushtronex System90066552021-12-13
10358406480016AutoTouch Connect reusable autoinjector90069402021-11-08
00358406425348Enbrel 25 mg/vial Multiple-use Vial6425342019-10-24
10358406425345Enbrel 25 mg/vial Multiple-use Vial6425342019-10-24
00355513192019Onpro kit90021362019-09-24
10355513192016Onpro kit90021362019-09-24
10355513770016Repatha Pushtronex System90028702019-09-24
10358406470017AutoTouch reusable autoinjector90036002019-09-24

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