DEVICE: Enbrel 25 mg/vial Replacement (00358406425911)
Device Identifier (DI) Information
Enbrel 25 mg/vial Replacement
642591
In Commercial Distribution
AMGEN INC.
642591
In Commercial Distribution
AMGEN INC.
Each single-dose vial contains 25 mg (0.5 mL) of Enbrel.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
41222 | 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.
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FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
FMF | Syringe, Piston |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep Enbrel out of the reach of children |
Special Storage Condition, Specify: Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C). |
Special Storage Condition, Specify: 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. |
Special Storage Condition, Specify: Do not shake |
Special Storage Condition, Specify: Do not freeze or store in extreme heat or cold. |
Special Storage Condition, Specify: Store Enbrel in the original carton to protect from light or damage. |
Clinically Relevant Size
[?]Size Type Text |
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Length: 0.5 Inch |
Needle Gauge: 27 Gauge |
Device Record Status
4f5c5b29-5911-48a1-bade-1b28d462c924
December 22, 2021
1
December 13, 2021
December 22, 2021
1
December 13, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10358406425918 | 16 | 00358406425911 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined