Medline
DBD-SYR W/NDLE,HYPODERM,LL,22GX 1", 10ML
60manufacturers in China registered for this device type
127catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| 510(k) | K112057 |
| Record published | 2016-10-14 |
| Record revised | 2025-11-18 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry. Handle with Care. |
| Packaging | Box of 100, case of 400, case of 800, pack of 800, case of 8 |
| Sizes | Total volume 0.3 to 10 ml; length 0.5 to 1.5 in; weight 20 to 28 g |
| Distribution end date | 2025-11-17 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SYRS103217 | 100 | In distribution | |
| SYRS103255 | 100 | In distribution | |
| DNSC83086A | 1,400 | In distribution | |
| SYRI101292 | In distribution | ||
| SYRS100225 | 100 | In distribution | |
| SYR111022 | In distribution | ||
| SYR110322 | In distribution | ||
| SYR110225 | In distribution | ||
| INS012805 | In distribution | ||
| SYR105010PC | In distribution | ||
| SYR110207A | Total Volume 10 ml | In distribution | |
| SYRS100207 | 100 | In distribution | |
| SYRS100187 | 100 | In distribution | |
| SYR101272A | Length 0.5 in | In distribution | |
| SYR103227 | In distribution | ||
| DNSC83078A | 250 | In distribution | |
| SSN100187 | In distribution | ||
| SYRS100195 | 100 | In distribution | |
| DNSC83080 | 100 | In distribution | |
| SYR110522 | In distribution | ||
| DNSC58135 | 100 | In distribution | |
| SSN100215 | In distribution | ||
| SYRS103227 | 100 | In distribution | |
| SYR110217 | In distribution | ||
| SYR160010PC | In distribution | ||
| SSN100237 | In distribution | ||
| SYRI101314 | Total Volume 1 ml | In distribution | |
| SYR103217A | Length 1.5 in | In distribution | |
| SYRI005314 | In distribution | ||
| SYR110235A | Total Volume 3 ml | In distribution | |
| SYR110010A | In distribution | ||
| SYRS103253 | 100 | In distribution | |
| SYRS100197 | 100 | In distribution | |
| SYR101010LD | In distribution | ||
| SSN100207 | In distribution | ||
| SSN100255 | In distribution | ||
| SYRI101304 | Total Volume 1 ml | In distribution | |
| SYR103010PC | In distribution | ||
| SYR120010A | In distribution | ||
| SYR103205A | Total Volume 3 ml | In distribution | |
| SYR101282A | Length 0.5 in | In distribution | |
| SYR101282 | In distribution | ||
| SYR110235 | 100 | In distribution | |
| SYR100165 | 100 | In distribution | |
| SYR103253A | Total Volume 3 ml | In distribution | |
| SYR103253 | 100 | In distribution | |
| SSN100272 | In distribution | ||
| SSN100273 | In distribution | ||
| SYR103205 | In distribution | ||
| SYR103225 | 100 | In distribution | |
| DNSC83081A | 700 | In distribution | |
| SYR130010A | In distribution | ||
| DNSC83089A | In distribution | ||
| SYR110217A | Length 1.5 in | In distribution | |
| SYRA101272 | In distribution | ||
| SSN100205 | In distribution | ||
| SYR101272 | 100 | In distribution | |
| SSN100217 | In distribution | ||
| SSN103235 | In distribution | ||
| SSN100225 | In distribution | ||
| SYR105205A | Weight 20 g | In distribution | |
| SSN101392F | In distribution | ||
| SSN100257 | In distribution | ||
| SYR110205A | Weight 20 g | In distribution | |
| SYR103020A | In distribution | ||
| SYR101020A | Total Volume 1 ml | In distribution | |
| SSN100227 | In distribution | ||
| SYR110225A | Length 1 in | In distribution | |
| SYRS100276 | 100 | In distribution | |
| SYR103227A | Length 1.5 in | In distribution | |
| SYR110227A | Total Volume 10 ml | In distribution | |
| SYR103225A | Total Volume 3 ml | In distribution | |
| SYR110215A | Length 1 in | In distribution | |
| SYRS100205 | In distribution | ||
| SYR120020A | In distribution | ||
| SYRS100253 | 100 | In distribution | |
| SYRS101255F | 100 | In distribution | |
| SYR103226 | In distribution | ||
| SSN103255 | In distribution | ||
| SYR130010PC | In distribution | ||
| SYRS101272F | 100 | In distribution | |
| DYNDV1672 | In distribution | ||
| SSN103225 | In distribution | ||
| SSN103217 | In distribution | ||
| DYNDA2031A | In distribution | ||
| SSN100302 | In distribution | ||
| SYR105020A | In distribution | ||
| SYR120010PC | In distribution | ||
| SYR101010A | In distribution | ||
| SSN100253 | In distribution | ||
| SYR105207 | Weight 20 g | In distribution | |
| DNSC83084A | 2,000 | In distribution | |
| SSN103215 | In distribution | ||
| SYR110020A | In distribution | ||
| SSN100276 | In distribution | ||
| SYR103215A | Total Volume 3 ml | In distribution | |
| SYR103010A | In distribution | ||
| SYRS103235 | 100 | In distribution | |
| SYR110010PC | In distribution | ||
| INS013005 | In distribution | ||
| SSN100185 | In distribution | ||
| SYRS100262 | 100 | In distribution | |
| SYRI003314 | Total Volume 0.3 ml | In distribution | |
| SYR105207A | Weight 20 g | In distribution | |
| SYR105010A | In distribution | ||
| SYR130020A | In distribution | ||
| SYR105217A | Length 1.5 in | In distribution | |
| DNSC83088A | In distribution | ||
| SYR100252 | 100 | In distribution | |
| SYR193272 | In distribution | ||
| SYRS100185 | 100 | In distribution | |
| SSN100195 | In distribution | ||
| SSN100235 | In distribution | ||
| SYR110020 | Withdrawn | ||
| SYR130010 | 40 | Withdrawn | |
| SYR120010 | 40 | Withdrawn | |
| SYR110010 | 100 | Withdrawn | |
| SYR160010 | 40 | Withdrawn | |
| SYR101010 | 100 | Withdrawn | |
| SYR103010 | 100 | Withdrawn | |
| SYR101020 | Withdrawn | ||
| SYR160020 | CS-EA;BX-EA; | Withdrawn | |
| INS012905 | Withdrawn | ||
| SYR105010 | 100 | Withdrawn | |
| SYR130020 | 40 | Withdrawn | |
| SYR103020 | Withdrawn | ||
| SYR120020 | 40 | Withdrawn |
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 |
| 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 |
| Integra® | Integra Pain Management | 77 |
Showing 12 of 913. All products under Syringe, Piston
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213054 | 2022-12-09 |
| K061275 | 2006-07-19 |
| K792033 | 1979-11-16 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2024-04-22 | Class II | Under Investigation by firm | It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health. | 25,214,334 syringes |
| Medline Industries, LP – Northfield | UDI-DI | 2024-04-22 | Class II | Under Investigation by firm | It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health. | 5,075,234 syringes |
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.