DEVICE: Enbrel 25 mg/vial Replacement (00358406425911)

Device Identifier (DI) Information

Enbrel 25 mg/vial Replacement
642591
In Commercial Distribution

AMGEN INC.
00358406425911
GS1

1
039976196 *Terms of Use
Each single-dose vial contains 25 mg (0.5 mL) of Enbrel.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
Yes
No

GMDN

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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.
Active false
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FDA Product Code

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Product Code Product Code Name
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
FMF Syringe, Piston
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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.
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Clinically Relevant Size

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Size Type Text
Length: 0.5 Inch
Needle Gauge: 27 Gauge
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Device Record Status

4f5c5b29-5911-48a1-bade-1b28d462c924
December 22, 2021
1
December 13, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10358406425918 16 00358406425911 In Commercial Distribution Case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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