Each single
Enbrel 25 mg/vial Replacement - 642591
Device Description
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.
Environmental Conditions
- Keep Enbrel out of the reach of children
- Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).
- 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.
- Do not shake
- Do not freeze or store in extreme heat or cold.
- Store Enbrel in the original carton to protect from light or damage.
Device Sizes
- Length: 0.5 Inch
- Needle Gauge: 27 Gauge
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 10358406425918
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00358406425911
Package Quantity: 16
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 00358406425911
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