Nipro Disposable Syringe
30mL Syringe, eccentric slip tip without needle
60manufacturers in China registered for this device type
36catalogue numbers in this listing
9510(k) clearances naming this product code
1recall
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 | Nipro Medical Corporation, United States |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Complaint-file establishment, Exporter |
| Record published | 2018-03-01 |
| Record revised | 2018-09-12 (version 3) |
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 |
| Packaging | Box of 100, case of 12, pack of 9, pack of 100, box of 200, pack of 15 |
| Sizes | Total volume 1 to 50 ml; length 0.5 to 1.5 in; needle gauge 20 to 27 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| JD+03L2238-WEI | Length 1.5 in | In distribution |
| JD+30ES-WEI | Total Volume 30 ml | In distribution |
| JD+50L-WEI | Total Volume 50 ml | In distribution |
| JD+20L-WEI | Total Volume 20 ml | In distribution |
| JD+01T2516-WEI | Total Volume 1 ml | In distribution |
| JD+10S | Total Volume : 10 mL | In distribution |
| JD+03L2338-WEI | Length 1.5 in | In distribution |
| JD+03L2325-WEI | Needle Gauge 23 G | In distribution |
| JD+05L2025-WEI | Total Volume 5 ml | In distribution |
| JD+01T-WEI | Total Volume 1 ml | In distribution |
| JD+05L-WEI | Total Volume 3 ml | In distribution |
| JD+01L-WEI | Total Volume 1 ml | In distribution |
| JD+01T2713-WEI | Total Volume 1 ml | In distribution |
| JD+30L-WEI | Total Volume 30 ml | In distribution |
| JD+03L2219-WEI | Total Volume 3 ml | In distribution |
| JD+05L2125-WEI | Needle Gauge 21 G | In distribution |
| JD+05L2138-WEI | Needle Gauge 21 G | In distribution |
| JD+10L2025 | Total Volume : 10 mL | In distribution |
| JD+03L2138-WEI | Length 1.5 in | In distribution |
| JD+03L2025-WEI | Total Volume 3 ml | In distribution |
| JD+03L2038-WEI | Length 1.5 in | In distribution |
| JD+10L2125 | Needle Gauge : 21 Gauge | In distribution |
| JD+03L-WEI | Total Volume 3 ml | In distribution |
| JD+10L | Total Volume : 10 mL | In distribution |
| JD+03L2225-WEI | Total Volume 3 ml | In distribution |
| JD+05L2225-WEI | Needle Gauge 22 G | In distribution |
| JD+50ES-WEI | Total Volume 50 ml | In distribution |
| JD+10L2038 | Needle Length : 1. 1/2 Inch | In distribution |
| JD+05L2238-WEI | Total Volume 5 ml | In distribution |
| JD+01D2516-WEI | Total Volume 1 ml | In distribution |
| JD+03L2125-WEI | Needle Gauge 21 G | In distribution |
| JD+10L2238 | Needle Gauge : 22 Gauge | In distribution |
| JD+03L2516-WEI | Total Volume 3 ml | In distribution |
| JD+10L2225 | Length 1 in | In distribution |
| JD+01T2609-WEI | Total Volume 1 ml | In distribution |
| JD+10L2138 | Needle Length : 1. 1/2 Inch | 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 |
|---|---|
| K212677 | 2022-04-15 |
| K191359 | 2019-10-09 |
| K173029 | 2018-03-30 |
| K131641 | 2013-08-28 |
| K130049 | 2013-02-14 |
| K091279 | 2009-08-12 |
| K051574 | 2005-08-26 |
| K030683 | 2003-10-31 |
| K000144 | 2000-02-11 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-01-13 | Not classified | Nonconforming Material/Component | Nipro Medical Corporation, Miami FL is initiating a nationwide recall of all GlucoPro Insulin syringes (This does not include the GlucoPro syringe specific for use with the amigo Insulin pump). These syringes may have needles that detach f | 2,268,600 pieces | 2010-09-15 |
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.