Enbrel 25 mg/vial Replacement

GUDID 10358406425918

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

AMGEN INC.

Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set Medication transfer set

• Primary Device ID: 10358406425918
• NIH Device Record Key: 4f5c5b29-5911-48a1-bade-1b28d462c924
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enbrel 25 mg/vial Replacement
• Version Model Number: 642591
• Company DUNS: 039976196
• Company Name: AMGEN INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 0.5 Inch
• Needle Gauge: 27 Gauge
• Length: 0.5 Inch
• Needle Gauge: 27 Gauge
• Length: 0.5 Inch
• Needle Gauge: 27 Gauge
• Length: 0.5 Inch
• Needle Gauge: 27 Gauge
• Length: 0.5 Inch
• Needle Gauge: 27 Gauge
• Length: 0.5 Inch
• Needle Gauge: 27 Gauge
• Length: 0.5 Inch
• Needle Gauge: 27 Gauge
• Length: 0.5 Inch
• Needle Gauge: 27 Gauge
• Length: 0.5 Inch
• Needle Gauge: 27 Gauge
• Length: 0.5 Inch
• Needle Gauge: 27 Gauge
• Length: 0.5 Inch
• Needle Gauge: 27 Gauge
• Length: 0.5 Inch
• Needle Gauge: 27 Gauge
• Length: 0.5 Inch
• Needle Gauge: 27 Gauge
• Length: 0.5 Inch
• Needle Gauge: 27 Gauge

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Enbrel out of the reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *Do not shake
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or store in extreme heat or cold.
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the original carton to protect from light or damage.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Enbrel out of the reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *Do not shake
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or store in extreme heat or cold.
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the original carton to protect from light or damage.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Enbrel out of the reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *Do not shake
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or store in extreme heat or cold.
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the original carton to protect from light or damage.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Enbrel out of the reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *Do not shake
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or store in extreme heat or cold.
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the original carton to protect from light or damage.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Enbrel out of the reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *Do not shake
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or store in extreme heat or cold.
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the original carton to protect from light or damage.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Enbrel out of the reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *Do not shake
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or store in extreme heat or cold.
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the original carton to protect from light or damage.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Enbrel out of the reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *Do not shake
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or store in extreme heat or cold.
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the original carton to protect from light or damage.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Enbrel out of the reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *Do not shake
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or store in extreme heat or cold.
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the original carton to protect from light or damage.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Enbrel out of the reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *Do not shake
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or store in extreme heat or cold.
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the original carton to protect from light or damage.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Enbrel out of the reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *Do not shake
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or store in extreme heat or cold.
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the original carton to protect from light or damage.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Enbrel out of the reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *Do not shake
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or store in extreme heat or cold.
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the original carton to protect from light or damage.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Enbrel out of the reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *Do not shake
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or store in extreme heat or cold.
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the original carton to protect from light or damage.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Enbrel out of the reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *Do not shake
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or store in extreme heat or cold.
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the original carton to protect from light or damage.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Enbrel out of the reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *Do not shake
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or store in extreme heat or cold.
• Special Storage Condition, Specify: Between 0 and 0 *Store Enbrel in the original carton to protect from light or damage.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00358406425911 [Primary]
GS1	10358406425918 [Package]; Contains: 00358406425911; Package: Case [16 Units]; In Commercial Distribution

FDA Product Code

• ONB: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-22
• Device Publish Date: 2021-12-13

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