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.

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.
Enbrel 25 mg/vial Multiple-use Vial - 642534

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.

• Length: 0.5 Inch
• Needle Gauge: 27 Gauge

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: ONB

Device Name: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Device Class: 2

Physical State: Vial adator with piercing spikes, contain Luer-Lock connector fitted with elastomeric membrane to provide a sealed connection between syringe, I.V. administration set or tranfer bag. May contain side pressure-equalizing protector unit. May contain needle-free access port.

Definition: Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Placed over vial or container containing the chemotheraphy drug

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Device is not act on any part of body. I.V. infusion devices, catheters, drug container closure system.

Regulation Number: 880.5440

Third Party Flag: N

Medical Specialty: HO

Code: FMF

Device Name: Syringe, Piston

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 880.5860

Third Party Flag: Y

Medical Specialty: HO

Device Id: 10358406425345

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00358406425348

Package Quantity: 8

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 00358406425348

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A