YI XIN Sterile Syringe for Single Use
YI XIN Sterile Syringe For Single Use, without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from the body.
60manufacturers in China registered for this device type
32catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (16), Zhejiang (15), Shanghai (11). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
Showing 12 of 60. All 60 manufacturers in China registered for Syringe, Piston
Record
| Listed by | Jiang Xi Sanxin Medtec Co., Ltd. |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| 510(k) | K050999 |
| Record published | 2019-09-26 |
| Record revised | 2019-10-08 (version 2) |
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, manufacturing date |
| Packaging | Pack of 100, pack of 24, pack of 12, pack of 16, pack of 30, pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Three-piece 2mL | In distribution | |
| Two-piece 5mL | In distribution | |
| Two-piece 10mL | In distribution | |
| Three-piece 3mL | In distribution | |
| Three-piece 2.5mL | In distribution | |
| Two-piece 2mL | In distribution | |
| Three-piece 5mL | In distribution | |
| Three-piece 20mL | In distribution | |
| Three-piece 10mL | In distribution | |
| Three-piece 30mL | In distribution | |
| Three-piece 60mL | In distribution | |
| Three-piece 2mL | In distribution | |
| Three-piece 30mL | In distribution | |
| Three-piece 1mL | In distribution | |
| Three-piece 50mL | In distribution | |
| Two-piece 5mL | In distribution | |
| Three-piece 3mL | In distribution | |
| Two-piece 3mL | In distribution | |
| Two-piece 1mL | In distribution | |
| Three-piece 2.5mL | In distribution | |
| Two-piece 20mL | In distribution | |
| Two-piece 2mL | In distribution | |
| Three-piece 50mL | In distribution | |
| Two-piece 10mL | In distribution | |
| Three-piece 5mL | In distribution | |
| Two-piece 3mL | In distribution | |
| Three-piece 10mL | In distribution | |
| Three-piece 1mL | In distribution | |
| Three-piece 60mL | In distribution | |
| Two-piece 20mL | In distribution | |
| Two-piece 1mL | In distribution | |
| Three-piece 20mL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 228 |
| Medallion® | Merit Medical Systems, Inc. | 223 |
| Merit Medical® | Merit Medical Systems, Inc. | 192 |
| Monoject | Cardinal Health | 188 |
| Medline | Medline Industries, Inc. | 127 |
| EasyTouch | MHC Medical Products | 122 |
| Medline Industries, Inc. | Medline Industries, Inc. | 99 |
| Arrow | Teleflex Medical LLC | 94 |
| Ceros | Rhino Medical Supply Inc | 92 |
| Enteral Feeding | Medela LLC | 87 |
| Monoject | Cardinal Health 200, LLC | 83 |
| HSW Soft-Ject® | Henke-Sass Wolf, Gmbh. | 80 |
Showing 12 of 913. All products under Syringe, Piston
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2023-08-08 | Class I | Device Design | There is a potential for blood backfill leakage and foreign material. | 124,773 boxes total |
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2023-08-08 | Class I | Device Design | There is a potential for blood backfill leakage and foreign material. | 124,773 boxes total |
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2023-08-08 | Class I | Device Design | There is a potential for blood backfill leakage and foreign material. | 124,773 boxes total |
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.