FDA.reportPublic FDA data

Enbrel 25 mg/vial Multiple-use Vial

Primary DI
00358406425348
Brand
Enbrel 25 mg/vial Multiple-use Vial
Company
AMGEN INC.
Model
642534
Device 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.
Published
2019-10-24
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
10358406425345PackageGS18In Commercial Distribution
00358406425348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035840642534510358406425345
00358406425348003584064253483584064253480358406425348

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, Specify00Before and after reconstitution refrigerate. DO NOT FREEZE.
Special Storage Condition, Specify00If needed, you may store your Enbrel multiple-dose vial and diluent syringe (dose tray) at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days.
Special Storage Condition, Specify00Once Enbrel multiple-dose vial has reached room temperature, do not put it back in the refrigerator.
Special Storage Condition, Specify00Store Enbrel multiple-dose vial in the original carton to protect from light or physical damage.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
039976196
Device count
1
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
00358406425911Enbrel 25 mg/vial Replacement6425912021-12-13
10355513770917Repatha Pushtronex System, sample90032432021-12-13
10358406425918Enbrel 25 mg/vial Replacement6425912021-12-13
10372511770015Repatha Pushtronex System90066552021-12-13
10358406480016AutoTouch Connect reusable autoinjector90069402021-11-08
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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