Sure Comfort
0.3mL 31G 8mm Single use disposable insulin syringe with needle and half unit measure. Includes 100 sterile syringes in convenient 10 pack bags.
60manufacturers in China registered for this device type
15catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls 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 | Allison Medical, Inc., United States |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Complaint-file establishment |
| 510(k) | K152879 |
| Record published | 2016-11-03 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 5, master case of 6, case of 6 |
| Sizes | Total volume 0.3 to 1 ml; length 8 to 12.7 mm; needle gauge 28 to 31 G |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 22-6505 | Total Volume 0.5 ml | 100 | In distribution |
| 22-9003 | Total Volume 0.3 ml | 100 | In distribution |
| 22-6003 | Needle Gauge 30 G | 100 | In distribution |
| 22-9010 | Total Volume 1 ml | 100 | In distribution |
| 22-6504 | Total Volume 0.3 ml | 100 | In distribution |
| 22-6010 | Needle Gauge 30 G | 100 | In distribution |
| 22-8010 | Total Volume 1 ml | 100 | In distribution |
| 22-6203 | Total Volume 0.3 ml | 100 | In distribution |
| 22-8005 | Needle Gauge 28 G | 100 | In distribution |
| 22-6205 | Needle Gauge 30 G | 100 | In distribution |
| 22-9005 | Needle Gauge 29 G | 100 | In distribution |
| 22-6503 | Needle Gauge 31 G | 100 | In distribution |
| 22-6510 | Needle Gauge 31 G | 100 | In distribution |
| 22-6005 | Total Volume 0.5 ml | 100 | In distribution |
| 22-6210 | Total Volume 1 ml | 100 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K984017 | 1999-03-04 |
| K932001 | 1994-01-21 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 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 |
| 2018-01-19 | Class II | Error in labeling | Insulin syringe retail packages incorrectly labeled as “Short Needle”. | 1,500 Boxes (150,000 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.