Monoject
188 catalogue numbers from 1180327114, listed by Cardinal Health, United States, under Syringe, Piston. 60 manufacturers in China are registered for this product code.
60manufacturers in China registered for this device type
188catalogue numbers in this listing
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 | Cardinal Health, United States |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K151949 |
| Record published | 2023-06-27 |
| Record revised | 2026-03-16 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| 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, serial number |
| Storage | Special storage condition: ; |
| Packaging | Case of 5, pack_or_inner_pack of 100, carton of 100, case of 6, case of 1000, case of 1200 |
| Sizes | Total volume 0.3 to 140 ml; length 0.31 to 1.5 in; needle gauge 21 to 30 G; total volume 18 Gallon; length 0.5 mm |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1180327114 | In distribution | ||
| 11832015 | In distribution | ||
| 8881560125 | 20 | In distribution | |
| 1180600555 | Total Volume 6 ml | In distribution | |
| 8881160629 | Total Volume 60 ml | 155 | In distribution |
| 8881535796 | Total Volume 35 ml | 30 | In distribution |
| 8881513918 | Total Volume 3 ml | 100 | In distribution |
| 8881513223 | Needle Gauge,22,Gauge; | 100 | In distribution |
| 1182000777 | Total Volume 20 ml | In distribution | |
| 8881135084 | Total Volume 35 ml | 25 | In distribution |
| 1186000444T | In distribution | ||
| 8881501970 | 100 | In distribution | |
| 11832215 | In distribution | ||
| 1180300777 | Total Volume 3 ml | In distribution | |
| 8881513512 | Total Volume 3 ml | 100 | In distribution |
| 8881501400 | Total Volume 1 ml | 100 | In distribution |
| 1188128012 | In distribution | ||
| 1181200555 | Total Volume 12 ml | In distribution | |
| 8881513033 | Total Volume 3 ml | 100 | In distribution |
| 5551032634 | Total Volume 3 ml | In distribution | |
| 8881600800 | In distribution | ||
| 1180322112 | In distribution | ||
| 8881516150 | Length 1.50 in | 50 | In distribution |
| 1180600777 | Total Volume 6 ml | In distribution | |
| 1180320100 | In distribution | ||
| 8881600004 | In distribution | ||
| 1180125158 | In distribution | ||
| 8881511144 | Length 0.5 mm | In distribution | |
| 8881501384 | Total Volume 1 ml | 100 | In distribution |
| 8881520673 | Total Volume 20 ml | 50 | In distribution |
| 8881511110 | Total Volume 1 ml | In distribution | |
| 8881513538 | Length 1 in | 100 | In distribution |
| 1180325058 | In distribution | ||
| 8881516200 | Total Volume 6 ml | 25 | In distribution |
| 8881600700 | In distribution | ||
| 8881114014 | Total Volume 140 ml | In distribution | |
| 1180126038 | In distribution | ||
| 8881106010 | Total Volume 6 ml | 100 | In distribution |
| 8881135068 | 25 | In distribution | |
| 1186000555 | In distribution | ||
| 8881103066 | Total Volume 3 ml | 2,000 | In distribution |
| 1180320112 | In distribution | ||
| 11813005 | In distribution | ||
| 8881520657 | Total Volume 20 ml | 50 | In distribution |
| 1188100555 | Total Volume 1 ml | In distribution | |
| 8881600145 | 100 | In distribution | |
| 8881501160 | Total Volume 1 ml | 100 | In distribution |
| 8881513256 | Total Volume 3 ml | 100 | In distribution |
| 8881500709 | Total Volume 0.50 ml | 100 | In distribution |
| 8881112075 | 100 | In distribution | |
| 8881160405 | Total Volume 60 ml | 20 | In distribution |
| 8881501459 | Total Volume 1 ml | 25 | In distribution |
| 8881560265 | 20 | In distribution | |
| 1180127012 | In distribution | ||
| 8881106028 | Total Volume 6 ml | 100 | In distribution |
| 1188100777 | Total Volume 1 ml | In distribution | |
| 1181200777T | In distribution | ||
| 1180325100 | In distribution | ||
| 8881501822 | Total Inner Volume,1,Milliliter | 100 | In distribution |
| 8881512860 | Total Volume 12 ml | 80 | In distribution |
| 1188100555 | In distribution | ||
| 8881600350 | In distribution | ||
| 1180322100 | In distribution | ||
| 8881520665 | 50 | In distribution | |
| 8881114030 | Total Volume 140 ml | In distribution | |
| 1180325114 | In distribution | ||
| 8881513231 | Needle Gauge,22,Gauge; | 100 | In distribution |
| 11812558 | In distribution | ||
| 8881511344 | Needle Gauge 30 G | In distribution | |
| 8881513058 | Total Volume 3 ml | 100 | In distribution |
| 1180128012 | In distribution | ||
| 8881511310 | Length 0.31 in | In distribution | |
| 1183500555 | Total Volume 35 ml | In distribution | |
| 1186000777 | In distribution | ||
| 1188528012 | In distribution | ||
| 8881516911 | Total Volume 6 ml | 50 | In distribution |
| 8881513744 | Needle Gauge,27,Gauge; | 100 | In distribution |
| 1182000555 | Total Volume 20 ml | In distribution | |
| 8881513132 | Total Volume 3 ml | 100 | In distribution |
| 8881511136 | Total Volume 0.50 ml | In distribution | |
| 1181200777 | Total Volume 12 ml | In distribution | |
| 1180321100 | In distribution | ||
| 1188127012 | Total Volume 1 ml | In distribution | |
| 1180100555 | Total Volume 1 ml | In distribution | |
| 1180323100 | In distribution | ||
| 8881120029 | 50 | In distribution | |
| 8881513025 | Needle Gauge,20,Gauge; | 100 | In distribution |
| 1180321112 | In distribution | ||
| 8881501368 | Length 0.50 in | 100 | In distribution |
| 11832115 | In distribution | ||
| 8881120037 | Total Volume 20 ml | 50 | In distribution |
| 1180100777 | Total Volume 1 ml | In distribution | |
| 11832558 | In distribution | ||
| 8881513157 | Needle Gauge,21,Gauge; | 100 | In distribution |
| 11832315 | In distribution | ||
| 8881513934 | Total Volume 3 ml | 100 | In distribution |
| 8881535762 | Total Volume 35 ml | 30 | In distribution |
| 8881513330 | Total Volume 3 ml | 100 | In distribution |
| 1180125058 | In distribution | ||
| 8881516937 | Total Volume 6 ml | 50 | In distribution |
| 8881560224 | 20 | In distribution | |
| 8881501178 | Total Volume 1 ml | 100 | In distribution |
| 8881511336 | Length 0.31 in | In distribution | |
| 8881106028 | Total Volume 6 ml | 100 | Withdrawn |
| 8881520251 | Total Volume 20 ml | 25 | Withdrawn |
| 11832310 | Withdrawn | ||
| 8881160256 | Total Volume 60 ml | 155 | Withdrawn |
| 8881501368 | Needle Gauge 27 G | 100 | Withdrawn |
| 1188100777 | Total Volume 1 ml | Withdrawn | |
| 8881501608 | 100 | Withdrawn | |
| 8881535762 | Total Volume 35 ml | 30 | Withdrawn |
| 8881501384 | Total Volume 1 ml | 100 | Withdrawn |
| 8881566023 | Total Volume 6 ml | 50 | Withdrawn |
| 8881516937 | Total Volume 6 ml | 50 | Withdrawn |
| 8881112083 | Total Volume 12 ml | 800 | Withdrawn |
| 8881560141 | Total Volume 60 ml | 20 | Withdrawn |
| 8881609145 | Length 0.50 in | Withdrawn | |
| 8881600806 | Total Volume 0.30 ml | Withdrawn | |
| 8881566015 | Total Volume 6 ml | 50 | Withdrawn |
| 8881511201 | Total Volume 1 ml | Withdrawn | |
| 11812705 | Withdrawn | ||
| 1181221100 | Withdrawn | ||
| 8881512746 | Needle Gauge 21 G | 80 | Withdrawn |
| 1183500888 | Total Volume 35 ml | Withdrawn | |
| 8881600848 | Needle Gauge,29,Gauge; | Withdrawn | |
| 1181220112 | Withdrawn | ||
| 8881500014 | 100 | Withdrawn | |
| 8881609600 | Length 0.3125 in | Withdrawn | |
| 11832110 | Withdrawn | ||
| 8881160405 | Total Volume 60 ml | 20 | Withdrawn |
| 1186000555T | Total Volume 60 ml | Withdrawn | |
| 8881160157 | 20 | Withdrawn | |
| 8881103066 | Total Volume 3 ml | 2,000 | Withdrawn |
| 8881512662 | 80 | Withdrawn | |
| 8881412012 | Total Volume 12 ml | 50 | Withdrawn |
| 8881560182 | Total Volume 60 ml | 20 | Withdrawn |
| 8881120037 | Total Volume 20 ml | 50 | Withdrawn |
| 8881520673 | Total Volume 20 ml | 50 | Withdrawn |
| 1186000555T | Total Volume 60 ml | Withdrawn | |
| 8881511235 | Needle Gauge,25,Gauge; | Withdrawn | |
| 8881501160 | Needle Gauge 25 G | 100 | Withdrawn |
| 8881516051 | 50 | Withdrawn | |
| 1186000777T | Total Volume 60 ml | Withdrawn | |
| 8881609101 | Total Volume 1 ml | Withdrawn | |
| 8881512852 | Total Volume 12 ml | 80 | Withdrawn |
| 8881501962 | Needle Gauge,27,Gauge; | 25 | Withdrawn |
| 8881160629 | Total Volume 60 ml | 155 | Withdrawn |
| 1186000777T | Total Volume 60 ml | Withdrawn | |
| 11832010 | Withdrawn | ||
| 8881609350 | Total Volume 0.50 ml | Withdrawn | |
| 8881520657 | Total Volume 20 ml | 50 | Withdrawn |
| 1181200777T | Total Volume 12 ml | Withdrawn | |
| 8881500105 | 100 | Withdrawn | |
| 1180100555 | Withdrawn | ||
| 11832210 | Withdrawn | ||
| 8881560232 | Total Volume 60 ml | 10 | Withdrawn |
| 8881609231 | Total Volume 0.50 ml | Withdrawn | |
| 8881609331 | Length 0.3125 in | Withdrawn | |
| 8881512977 | Total Volume 12 ml | Withdrawn | |
| 8881516911 | Total Volume 6 ml | 50 | Withdrawn |
| 1180600555 | Total Volume 6 ml | Withdrawn | |
| 8881535796 | Total Volume 35 ml | 30 | Withdrawn |
| 8881501210 | 100 | Withdrawn | |
| 1183500777 | Total Volume 35 ml | Withdrawn | |
| 8881112059 | Total Volume 12 ml | 100 | Withdrawn |
| 8881512878 | Total Volume 12 ml | 80 | Withdrawn |
| 8881512811 | 80 | Withdrawn | |
| 8881513207 | Total Volume 3 ml | 25 | Withdrawn |
| 8881516135 | Total Volume 6 ml | 50 | Withdrawn |
| 11832510 | Withdrawn | ||
| 8881114063 | Withdrawn | ||
| 1181221112 | Withdrawn | ||
| 8881106010 | Total Volume 6 ml | 100 | Withdrawn |
| 8881501640 | Total Volume 1 ml | 100 | Withdrawn |
| 8881135084 | Total Volume 35 ml | 25 | Withdrawn |
| 8881609004 | Total Volume 0.50 ml | Withdrawn | |
| 8881609131 | Total Volume 1 ml | Withdrawn | |
| 8881512597 | 80 | Withdrawn | |
| 8881501178 | Length 0.37 in | 100 | Withdrawn |
| 8881501400 | Total Volume 1 ml | 100 | Withdrawn |
| 8881520178 | Total Volume 20 ml | Withdrawn | |
| 8881535788 | Total Volume 35 ml | 30 | Withdrawn |
| 8881609358 | Length 0.50 in | Withdrawn | |
| 8881609800 | Needle Gauge,30,Gauge; | Withdrawn | |
| 8881512258 | Total Volume 12 ml | 25 | Withdrawn |
| 1181218100 | Withdrawn | ||
| 8881535101 | Total Volume 35 ml | 10 | Withdrawn |
| 8881609700 | Length 0.3125 in | 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 |
| 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 |
| Integra® | Integra Pain Management | 77 |
Showing 12 of 913. All products under Syringe, Piston
Recalls Naming This Product
7 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cardinal Health 200, LLC | UDI-DI | 2026-02-27 | Class II | Under Investigation by firm | The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes. | 198,900 units |
| Cardinal Health 200, LLC | UDI-DI | 2024-09-25 | Class I | Under Investigation by firm | Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be u | 371,326 units |
| Mckesson Medical-Surgical Inc. Corporate Office | UDI-DI | 2024-04-23 | Class II | Component change control | Quarantined product was inadvertently distributed | 5 Boxes (20 per box, 100 eaches) |
| Cardinal Health 200, LLC | UDI-DI | 2023-12-28 | Class I | Process change control | Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile | |
| Cardinal Health 200, LLC | UDI-DI | 2023-12-28 | Class I | Process change control | Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile | |
| Cardinal Health 200, LLC | UDI-DI | 2023-09-20 | Class I | Vendor change control | Demonstrated recognition and compatibility issues with syringe infusion pumps. | 3,084,300 units |
| Cardinal Health 200, LLC | UDI-DI | 2023-09-20 | Class I | Vendor change control | Demonstrated recognition and compatibility issues with syringe infusion pumps. | 457,200 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.