AccessGUDID - DEVICE: Enbrel 25 mg/vial Replacement (00358406425911)

GUDID

Device Identifier (DI) Information

Brand Name: Enbrel 25 mg/vial Replacement
Version or Model: 642591
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMGEN INC.

Primary DI Number: 00358406425911
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039976196 *Terms of Use

Device Description: Each single-dose vial contains 25 mg (0.5 mL) of Enbrel.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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.

Clinically Relevant Size

[?]

Size Type Text
Length: 0.5 Inch
Needle Gauge: 27 Gauge

Device Record Status

Public Device Record Key: 4f5c5b29-5911-48a1-bade-1b28d462c924
Public Version Date: December 22, 2021
Public Version Number: 1
DI Record Publish Date: 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
No Secondary DIs found

Unit of Use DI

[?]

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

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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