Vial2Bag Advanced 20mm Admixture Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240940 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 20mm 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 IV bag, a vial with 20mm closure, and an external IV administration set. The integrated Vial Adapter allows for the reconstitution and/or admixing of drugs.
The device is supplied as a single-use product and is designed for use in pharmacy settings. It is available in the 20mm size as specified in the product name. The device has received FDA 510K clearance with the product code LHI and was reviewed under the General Hospital advisory committee.
Frequently asked questions
What is the Vial2Bag Advanced 20mm Admixture Device used for?
The Vial2Bag Advanced 20mm 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 IV bag, a vial with 20mm closure, and an external IV administration set.
How is the Vial2Bag Advanced 20mm Admixture Device supplied?
The device is supplied as a single-use product and is designed for use in pharmacy settings. It is available in the 20mm size as specified in the product name. The integrated Vial Adapter allows for the reconstitution and/or admixing of drugs.
What regulatory approvals does the Vial2Bag Advanced 20mm Admixture Device have?
The device has received FDA 510K clearance with the product code LHI and was reviewed under the General Hospital advisory committee. It was determined to be substantially equivalent and received a special clearance type.
What IV bag sizes are compatible with the Vial2Bag Advanced 20mm Admixture Device?
The Vial2Bag Advanced 20mm Admixture Device is compatible with 50, 100, or 250mL IV bags. It connects these bags to vials with 20mm closures and external IV administration sets for drug reconstitution and transfer.
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, Vial2Bag Advanced Admixture Device - 20mm - Progressive Medical, Inc., Vial2Bag Advanced® admixture device Instructions for Use (IFU), West Pharmaceutical | Progressive Medical, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240940 | Class II | Active |
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Manufacturer
- Manufacturer
- West Pharmaceutical Services, Inc.
Sources (1)
- FDA 510(k) K240940 24 fields · synced Oct 6, 2026