Vented Vial Adapter
The Vented Vial Adapter connects a drug vial to a standard Luer syringe for mixing, reconstitution and withdrawal of the vial’s contents. It is a prescription device for healthcare…
The Vented Vial Adapter connects a drug vial to a standard Luer syringe for mixing, reconstitution and withdrawal of the vial’s contents. It is a prescription device for healthcare professionals in clinical, hospital or other healthcare settings.
An integrated plastic spike pierces the vial’s elastomeric septum. Pushing the adapter fully onto the vial seats its housing around the ferrule, creating a snap-fit connection. The opposite end has a female Luer fitting for the syringe.
Listed Item
The Vented vial adapter consists of an interface, a lid, a housing, a filter membrane and a puncture section; the interface, the lid, the housing and the puncture section are made of polycarbonate (PC) and the filter membrane is made of polyethylene terephthalate (PET) and polytetrafluoroethylene (PTFE). The vial adapter is indicated for the transfer and mixing of drugs contained in vials.
Construction and Supply
The adapter has a polycarbonate housing and connector components with a filter membrane. It is supplied sterile following electron-beam irradiation and is intended for single use.
Who Else Makes It
Concentrated in Zhejiang (3), Jiangsu (3), Hong Kong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Zhejiang Medtec Medical devices Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 10 |
| Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
Record
| Listed by | Hangzhou Qiantang Longyue Biotechnology Co., Ltd., China |
|---|---|
| FDA product code | LHI |
| Device type | Set, I.V. Fluid Transfer |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Manufacturer |
| 510(k) | K233287 |
| Record published | 2026-04-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Secondary box of 150, carton of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VA-AF13S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kenaflexx | Kentron Healthcare, Inc. | 49 |
| Set, I.V. Fluid Transfer | Mps Medical, Inc. | 27 |
| Vial Adaptor | West Pharma. Services IL, Ltd. | 26 |
| Vial Adapter | West Pharma. Services IL, Ltd. | 22 |
| Extension SET | MPS Pharma & Medical, Inc. | 19 |
| Vial Adapter Medic’up | Union Plastic | 17 |
| Exactamix | Baxter Healthcare Corporation | 16 |
| Mix2Vial Transfer Device | West Pharma. Services IL, Ltd. | 15 |
| Arisure | Yukon Medical, LLC | 13 |
| ViaLok | Yukon Medical, LLC | 12 |
| ICU Medical | ICU Medical, Inc | 12 |
| Codan | Codan US Corp. | 10 |
Showing 12 of 233. All products under Set, I.V. Fluid Transfer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260301 | 2026-06-05 |
| K233287 | 2024-07-26 |
| K233284 | 2024-05-01 |
| K222718 | 2023-03-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.