Enbrel 25 mg/vial Replacement

GUDID 10358406425918

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

AMGEN INC.

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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