FDA.reportPublic FDA data

Enbrel 25 mg/vial Replacement

Primary DI
10358406425918
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
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
039976196
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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18859299133857ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2026-03-11
00382905156298BD PhaSeal OptimaBD Switzerland SàrlONB2026-01-09
00382905156281BD PhaSeal OptimaBD Switzerland SàrlONB2025-12-19
18859299119950ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299124114ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299124121ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299124138ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299124145ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299124152ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299130696ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299130702ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299130719ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
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27290115921759OnGuard2 20mm Vial Adaptor, 10 UnitsSIMPLIVIA HEALTHCARE LTDONB2024-09-08
27290115921872OnGuard2 20mm Vial Adaptor, 5 UnitsSIMPLIVIA HEALTHCARE LTDONB2024-09-08
27290115921889OnGuard2 Syringe Adaptor, 5 UnitsSIMPLIVIA HEALTHCARE LTDONB2024-09-08
27290115921896OnGuard2 Syringe Adaptor Lock II, 5 UnitsSIMPLIVIA HEALTHCARE LTDONB2024-09-08
27290115921865OnGuard2 Bag Adaptor SP IISIMPLIVIA HEALTHCARE LTDONB2024-05-06
27290115921827OnGaurd2 CSTD Catheter Adaptor SIMPLIVIA HEALTHCARE LTDONB2023-09-12
10885403470127MaxZeroBD Switzerland SàrlONB2023-07-27
00382905153013BD PhaSealBECTON DICKINSON PEN LIMITEDONB2023-07-27
00840619023720ICU MedicalICU MEDICAL, INC.ONB2023-06-02
00382905150708BD PhaSeal OptimaBD Switzerland SàrlONB2023-05-10
00382905153020BD PhaSealBD Switzerland SàrlONB2023-05-10
00382905154065BD PhaSealBD Switzerland SàrlONB2023-05-10
00382905150784BD PhaSeal OptimaBD Switzerland SàrlONB2023-04-26