Injectable drug administration systems developer West Pharmaceutical Services has announced the US Food and Drug Administration (FDA) 510(k) clearance of the Vial2Bag Advanced 13mm admixture device and its subsequent launch.
The product is said to be a needle-free device with a sturdy vial spike design for connecting to the medication vial. It also has a dual channel design for providing specific fluid paths into and out of the IV bag.
The addition of the Vial2Bag Advanced 13mm admixture device complements the company’s existing FDA-cleared Vial2Bag Advanced 20mm admixture device.
These two products offer options for the reconstitution and transfer of a drug using an IV bag and either a 13mm or 20mm vial before patient administration, according to West Pharmaceutical Services.
West Pharmaceutical Services chief commercial officer Cindy Reiss-Clark said: “This year, West celebrates 100 years as an industry leader and scientific innovator in high-quality injectable solutions.
“The 13mm product is a key addition to our administration system portfolio, addressing the critical need for more drug preparation and delivery options at the point-of-care.”
The Vial2Bag Advanced 13mm admixture device is indicated to connect a 50, 100, or 250ml IV bag, vial with 13mm closure with an external IV administration set.
West Pharmaceutical Services said that the device has an integrated vial adapter that allows it to reconstitute and/or admix medications before giving them to adolescents or adult patients.
Headquartered in Exton, Pennsylvania, West Pharmaceutical Services offers different injectable solutions and services for safe, effective containment and delivery of life-saving and life-enhancing medications for patients.
The company is listed on the New York Stock Exchange and is included on the Standard & Poor’s 500 index.