Vygon
10" Winged Infusion SET With 20 GA. X 0.75" Huber Needle AND Needleless Y-Site
71manufacturers in China registered for this device type
31catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (20), Zhejiang (19), Shanghai (12). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Aena Medical (Jiangsu) Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 4 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 71. All 71 manufacturers in China registered for Needle, Hypodermic, Single Lumen
Record
| Listed by | Vygon Corp., United States |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| 510(k) | K873957 |
| Record published | 2016-08-16 |
| Record revised | 2019-10-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 21, pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MBS-2010 | In distribution | |
| MBS-2034 | In distribution | |
| MBS-1910 | In distribution | |
| MBS-2034 | In distribution | |
| MSY-2034 | In distribution | |
| MBS-2010-1 | In distribution | |
| MBS-2234-1 | In distribution | |
| MBS-2034-1 | In distribution | |
| MSY-1910 | In distribution | |
| MBS-2210 | In distribution | |
| MBS-2250 | In distribution | |
| MBS-2210 | In distribution | |
| MSY-2015 | In distribution | |
| MBS-2015 | In distribution | |
| MSY-2210 | In distribution | |
| MBS-2234 | In distribution | |
| MBS-2234 | In distribution | |
| MSY-2210 | In distribution | |
| MSY-2234 | In distribution | |
| MBS-1910 | In distribution | |
| MSY-2010-1 | In distribution | |
| MBS-2010 | In distribution | |
| MBS-2015 | In distribution | |
| MSY-2034-1 | In distribution | |
| MBS-2210-1 | In distribution | |
| MSY-1915 | In distribution | |
| MSY-2010 | In distribution | |
| MSY-2010 | In distribution | |
| MSY-2234 | In distribution | |
| MSY-2234-1 | In distribution | |
| MSY-2034 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterile Single-use Syringe with Needle | Jiangxi Hongda Medical Equipment Group Ltd. | 162 |
| Tkmd | Anhui Tiankang Medical Technology Co., Ltd. | 150 |
| Reli | Myco Medical Supplies, Inc. | 149 |
| STERiJECT TM | TSK Laboratory, Japan | 140 |
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 130 |
| Monoject | Cardinal Health | 124 |
| Monoject | Cardinal Health 200, LLC | 112 |
| Jelco | ICU Medical, Inc | 108 |
| micsafe | Jiangsu Micsafe Medical Tehcnology Co., Ltd. | 105 |
| McKesson | Mckesson Medical-Surgical Inc. | 93 |
| EasyTouch | MHC Medical Products | 82 |
| Medegen Medical products | Medegen Medical Products | 78 |
Showing 12 of 797. All products under Needle, Hypodermic, Single Lumen
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K963571 | 1997-06-02 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Vygon MFG | 510(k) number | 2017-07-24 | Class II | Under Investigation by firm | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing g | 156 | 2019-11-07 |
| Vygon MFG | 510(k) number | 2012-04-16 | Not classified | Labeling False and Misleading | Mislabeled: MBS-2210 code on case label -22Ga Winged Infusion Set, ; however, the product label states 20Ga MBS-2010 code listed on device label. | 552 units | 2013-03-28 |
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.