Vial2Bag Advanced 13mm Admixture Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230988 FDA 510(k)
- FDA Product Code
- LHI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vial2Bag Advanced 13mm Admixture Device is a needle-free device that enables reconstitution and transfer of drugs from a vial to an IV bag prior to administration to the patient. It serves as a connection between a 50, 100 or 250mL V bag, a vial with 13mm closure, and an external IV administration set.
The device is supplied as a single-use, sterile medical device. It is Class 2 registered in Canada and has received FDA 510K clearance as substantially equivalent. The device should not be interpreted as modifying, extending, or superseding a drug manufacturer's labeling recommendations for storage and expiration dating unless otherwise limited by applicable compounding standards.
Frequently asked questions
What types of IV bags and vials can the Vial2Bag Advanced® 13mm Admixture Device connect to, and how does it work?
The Vial2Bag Advanced® 13mm Admixture Device connects between a 50mL, 100mL, or 250mL IV bag and a vial with a 13mm closure, enabling needle-free reconstitution and transfer of medications. It serves as a direct link between the vial and an external IV administration set, allowing safe and efficient admixture without direct needle insertion into the vial or bag.
Is the Vial2Bag Advanced® 13mm Admixture Device intended for single-use or repeated use, and how should it be handled to maintain sterility?
The device is strictly single-use and supplied sterile. Since it is designed for one-time use, it must be discarded after each procedure to prevent contamination. Sterility is maintained through proper handling—only open the packaging immediately before use, avoid touching the sterile surfaces, and follow standard aseptic technique to minimize exposure to microorganisms.
Does the device require any special storage conditions, and what should I consider when storing unused units?
The Vial2Bag Advanced® does not specify unusual storage conditions beyond standard medical device guidelines. Unused units should be stored in their original, sealed packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Ensure the packaging remains intact to preserve sterility until use.
How does the Vial2Bag Advanced® differ from traditional needle-based admixture methods, and what are the key benefits?
Unlike traditional needle-based methods, the Vial2Bag Advanced® is needle-free, eliminating the risk of needle sticks, accidental pricks, and potential contamination from sharp instruments. It simplifies the transfer process by providing a direct, secure connection between the vial and IV bag, reducing user error and improving workflow efficiency in reconstitution and admixture tasks.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Vial2Bag Advanced® Needle-Free Admixture Devices, PDF The Vial2Bag Advanced® Admixture Device, Vial2Bag Advanced® 13mm Admixture Device by West Pharma Services IL ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230988 | Class II | Active |
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Manufacturer
- Manufacturer
- West Pharma. Services IL, Ltd.
Sources (1)
- FDA 510(k) K230988 24 fields · synced Sep 19, 2026