SmartSite
CareFusion SmartSite VialShield Universal Closed Vial Access Device
8manufacturers in China registered for this device type
10catalogue numbers in this listing
8510(k) clearances naming this product code
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 | Yukon Medical, LLC, 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 |
| Record published | 2017-04-06 |
| Record revised | 2023-06-12 (version 4) |
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 |
| Packaging | Case of 50, box of 50, case of 2, case of 10, case of 100, case of 20 |
| Sizes | Lumen/inner diameter 13 to 28 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MV0428 | Lumen/Inner Diameter 28 mm | In distribution | |
| MV0413 | Lumen/Inner Diameter 13 mm | In distribution | |
| MV0513 | Lumen/Inner Diameter 13 mm | In distribution | |
| MV0420 | Lumen/Inner Diameter 20 mm | In distribution | |
| MV0520 | Lumen/Inner Diameter 20 mm | In distribution | |
| MV040010 | 10 | In distribution | |
| MV0400 | In distribution | ||
| MV0550 | In distribution | ||
| MV0528 | Lumen/Inner Diameter 28 mm | In distribution | |
| MV042005 | Lumen/Inner Diameter 20 mm | 5 | 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 |
|---|---|
| K240761 | 2025-03-21 |
| K243486 | 2024-12-06 |
| K172884 | 2017-10-03 |
| K172631 | 2017-09-29 |
| K151963 | 2015-07-31 |
| K132863 | 2013-10-04 |
| K122265 | 2012-08-14 |
| K121182 | 2012-05-03 |
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.