AccessGUDID - DEVICE: Enbrel 25 mg/vial Multiple-use Vial (00358406425348)

GUDID

Device Identifier (DI) Information

Brand Name: Enbrel 25 mg/vial Multiple-use Vial
Version or Model: 642534
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMGEN INC.

Primary DI Number: 00358406425348
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039976196 *Terms of Use

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.

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

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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

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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

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Storage and Handling
Special Storage Condition, Specify: Once Enbrel multiple-dose vial has reached room temperature, do not put it back in the refrigerator.
Special Storage Condition, Specify: If 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, Specify: Store Enbrel multiple-dose vial in the original carton to protect from light or physical damage.
Special Storage Condition, Specify: Before and after reconstitution refrigerate. DO NOT FREEZE.
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

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

Device Record Status

Public Device Record Key: adee0cb6-04c9-4be6-a760-406a195ca6e1
Public Version Date: November 01, 2019
Public Version Number: 1
DI Record Publish Date: October 24, 2019