Endure
Insulin Syringes with Needle, 31G, 5mm, 0.5ml (50 units), Sterile
60manufacturers in China registered for this device type
20catalogue 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 | Endure Industries, Inc., United States |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K132553 |
| Record published | 2020-08-31 |
| Record revised | 2026-03-02 (version 2) |
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, manufacturing date |
| Storage | Storage environment temperature 0 to 49 °C |
| Packaging | Box of 100, case of 20, case of 24, case of 16, case of 8, box of 50 |
| Sizes | Total volume 0.3 to 50 ml; needle gauge 31 G; catheter length 5 to 8 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SLL5A3-0520 | Total Volume 5 ml | In distribution |
| SN3155A4-0520 | Needle Gauge 31 G | In distribution |
| SLS2A3-0520 | Total Volume 2 ml | In distribution |
| SN3153A4-0520 | Needle Gauge 31 G | In distribution |
| SLS3A3-0520 | Total Volume 3 ml | In distribution |
| SLS5A3-0520 | Total Volume 5 ml | In distribution |
| SLL10A3-0520 | Total Volume 10 ml | In distribution |
| SLL2A3-0520 | Total Volume 2 ml | In distribution |
| SLL50A3-0520 | Total Volume 50 ml | In distribution |
| SN3151A4-0520 | Needle Gauge 31 G | In distribution |
| SLL20A3-0520 | Total Volume 20 ml | In distribution |
| SLL1A3-0520 | Total Volume 1 ml | In distribution |
| SLL3A3-0520 | Total Volume 3 ml | In distribution |
| SLS20A3-0520 | Total Volume 20 ml | In distribution |
| SLS1A3-0520 | Total Volume 1 ml | In distribution |
| SLS50A3-0520 | Total Volume 50 ml | In distribution |
| SN3183A4-0520 | Needle Gauge 31 G | In distribution |
| SN3185A4-0520 | Needle Gauge 31 G | In distribution |
| SN3181A4-0520 | Needle Gauge 31 G | In distribution |
| SLS10A3-0520 | Total Volume 10 ml | 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
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 |
|---|---|---|---|---|---|---|
| Allison Medical, Inc. | 510(k) number | 2020-09-03 | Class II | Nonconforming Material/Component | Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown. | 2,004 Boxes |
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.