BD Micro-Fine
BD Insulin Syringes with the BD Micro-Fine IV Needle, U-100, 12.7mm, 28G, 1mL, 2 units
60manufacturers in China registered for this device type
6catalogue numbers in this listing
14510(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 | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-08-03 |
| Record revised | 2025-05-12 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 5 |
| Sizes | Total volume 0.5 to 1 ml; length 12.7 to 16 mm; needle gauge 27 to 28 G |
| Distribution end date | 2029-11-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 329412 | Total Volume 1 ml | 100 | In distribution |
| 329424 | Total Volume 1 ml | 100 | In distribution |
| 329410 | Length 12.7 mm | 100 | In distribution |
| 329465 | Length 12.7 mm | 100 | In distribution |
| 329420 | Length 12.7 mm | 100 | In distribution |
| 329461 | Needle Gauge 28 G | 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 |
|---|---|
| K251350 | 2025-07-29 |
| K212499 | 2022-03-09 |
| K203359 | 2021-07-28 |
| K203453 | 2021-01-25 |
| K201234 | 2020-07-15 |
| K190054 | 2019-10-21 |
| K182589 | 2019-03-14 |
| K172670 | 2018-10-23 |
| K162081 | 2016-12-19 |
| K151870 | 2016-07-08 |
| K151766 | 2015-09-02 |
| K121283 | 2012-05-30 |
| K110771 | 2011-05-13 |
| K010890 | 2001-04-19 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | UDI-DI | 2023-02-01 | Class II | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. | 961,000 units |
| Becton, Dickinson & Co. | UDI-DI | 2023-02-01 | Class II | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. | 1,921,000 units |
| Becton, Dickinson & Co. | UDI-DI | 2023-02-01 | Class II | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. | 686,500 units |
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.