Tianzi
STERILE SYRINGE WITH NEEDLE FOR SINGLE USE 1ml Luer Slip 25G×1‘’, Rx Only, Non-toxic, Non-pyrogenic, Not made with natural rubber latex
60manufacturers in China registered for this device type
5catalogue numbers in this listing
40recalls on this 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 | Jiangsu Shenli Medical Production Co., Ltd., China |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K103830 |
| Record published | 2021-08-02 |
| Record revised | 2024-04-15 (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 |
| Packaging | Box of 100, pack of 100, pack of 40, case of 30, case of 24, case of 9 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1ml | In distribution | |
| 1ml Luer Slip 25G×1‘’ | In distribution | |
| 3ml Luer Lock 23G×1‘’ | In distribution | |
| 20ML | In distribution | |
| 10ml | 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
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 |
|---|---|---|---|---|---|---|
| Cypress Medical Products, Ltd. | 510(k) number | 2024-07-24 | Class II | Other | Affected syringes lack FDA clearance. | 24,693,200 eaches (US) |
| Medline Industries, LP – Northfield | 510(k) number | 2024-04-08 | Class II | Under Investigation by firm | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. |
Recalls
40 of these are Class II. Class II means a temporary or reversible health consequence. 40 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 348800 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 4092250 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 749400 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 139100 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 619200 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 230800 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 12000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 25200 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 454400 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 7000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 7000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 325500 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 0 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 62000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 13574000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 95200 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 525,700 syringes |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 777400 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 0 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 1248000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 1700000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 30800 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 400 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 1590000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 12600 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 116160 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 124800 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 44800 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 1117800 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 50400 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 303800 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 98700 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 4800 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 483210 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 7000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 0 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 37200 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 0 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 133600 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 40800 |
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.