// changes done below on July 01 2024 // till here on July 01 2024

West Pharmaceutical Services announces the FDA 510(k) clearance for Vial2Bag Advanced® 13mm Admixture device

Published: December 2023

On 04 December 2023, West Pharmaceutical Services, a prominent global entity specializing in pioneering solutions for injectable drug administration systems announced the FDA 510(k) clearance and launch of its latest innovation, the Vial2Bag Advanced® 13mm admixture device. This newly introduced device is an addition to West's existing Vial2Bag Advanced® 20mm admixture device, offering versatile options for the reconstitution and transfer of drugs from either a 13mm or 20mm vial to an IV bag before patient administration.

Notably, this needle-free device features a dual-channel design, ensuring dedicated fluid pathways into and out of the IV bag, coupled with a robust vial spike design for secure attachment to the drug vial. This device serves as a crucial connection between a 50, 100, or 250ml IV bag, a vial equipped with a 13mm closure, and an external IV administration set. Its integrated vial adapter enables the reconstitution and/or admixture of drugs before their administration to adolescent and adult patients. It is essential to note that the Vial2Bag Advanced® 13mm admixture device is specifically intended for adolescent and adult patient use.

Both the Vial2Bag Advanced® 13mm and 20mm admixture devices have received 510(k) clearance from the United States Food and Drug Administration (FDA). However these products are strictly for prescription use and are intended solely for healthcare professionals within the United States.

According to Roots Analysis, Wearable Injectors Market size is estimated to be worth USD 4.3 billion in 2023, growing at a CAGR of 9% during the forecasted period.

For detailed insights about this domain, check out our report on Wearable Injectors Market or email sales@rootsanalysis.com

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  1. Drug Device Combination Products Market, 2022-2035
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  3. Global Autoinjectors Market, 2021-2035


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