IVX Station Stock Solution Transfer Set
The IVX Station Stock Solution Transfer Set is a disposable tubing set used during pharmacy compounding. With the IVX Pharmacy Compounding Station, it transfers compounded drug solution…
The IVX Station Stock Solution Transfer Set is a disposable tubing set used during pharmacy compounding. With the IVX Pharmacy Compounding Station, it transfers compounded drug solution from an intravenous bag into a final syringe container for subsequent infusion preparation.
Trained healthcare personnel use the set with aseptic technique inside the compounding station’s ISO 5 environment.
Listed Item
The IVX Station Stock Solution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System for aseptic transfer of fluid from an I.V. bag of compounded drug into a final container(s) for use in the preparation of final compounded drugs for patient infusion administration.
Sterile Supply
The transfer set is gamma sterilized and intended for a single use. It is not intended for direct connection to a patient.
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 | Omnicell, Inc., United States |
|---|---|
| FDA product code | LHI |
| Device type | Set, I.V. Fluid Transfer |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K212530 |
| Record published | 2023-06-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Inner pack-shelf box of 5, case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IVX Station Stock Solution Transfer Set | 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 |
|---|---|
| K212530 | 2022-04-24 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Omnicell, Inc. | 510(k) number | 2025-02-20 | Class II | Process control | IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in | 3 |
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.