Monoject
Monoject™ Pharmaceutical Waste Container, PGII Gasketed Slide Lid, White, 18 Gallon
71manufacturers in China registered for this device type
124catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (20), Zhejiang (19), Shanghai (12). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Aena Medical (Jiangsu) Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 4 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 71. All 71 manufacturers in China registered for Needle, Hypodermic, Single Lumen
Record
| Listed by | Cardinal Health, United States |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K980062 |
| Record published | 2016-09-24 |
| Record revised | 2026-05-13 (version 13) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Special storage condition: Keep dry;AVOID DIRECT SUNLIGHT |
| Packaging | Case of 1000, pack_or_inner_pack of 100, case of 800, case of 20, case of 10, case of 480 |
| Sizes | Length 0.3125 to 2 in; total volume 2 to 18 Gallon; total volume 3 to 12 ml; outer diameter 13 mm |
| Distribution end date | 2027-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8881250115 | Length 1.50 in | 100 | In distribution |
| 8881250073 | Needle Gauge,19,Gauge; | 100 | In distribution |
| 8881250214 | Needle Gauge,22,Gauge; | 100 | In distribution |
| 1181910 | In distribution | ||
| 8881202033 | Total Volume 3 ml | 100 | In distribution |
| 1188819100 | Length 1 in | In distribution | |
| 8881250248 | Length 0.75 in | 100 | In distribution |
| 1188818113 | Needle Gauge,18,Gauge; | In distribution | |
| 8881541208 | Total Volume 12 ml | In distribution | |
| 89651 | Total Volume 2 Gallon | In distribution | |
| 8881541307 | Total Volume 3 ml | In distribution | |
| 1188825100 | Length 1 in | In distribution | |
| 05081 | Needle Gauge,20,Gauge; | 100 | In distribution |
| 1188821112 | Length 1.50 in | In distribution | |
| 8881200193 | Length 1.50 in | 100 | In distribution |
| 8881250313 | Length 0.625 in | 100 | In distribution |
| 1188825112 | Length 1.50 in | In distribution | |
| 1188821100 | Length 1 in | In distribution | |
| 1188822112 | Length 1.50 in | In distribution | |
| 1188820100 | Length 1 in | In distribution | |
| 1188826112 | Needle Gauge,26,Gauge; | In distribution | |
| 8881216025 | Needle Gauge,20,Gauge; | 50 | In distribution |
| 8881200383 | Needle Gauge,23,Gauge; | 100 | In distribution |
| 8881200466 | Length 0.625 in | 100 | In distribution |
| 1182110 | In distribution | ||
| 1182705 | In distribution | ||
| 8881250339 | Needle Gauge,20,Gauge; | 100 | In distribution |
| 8881216033 | Length 1 in | 50 | In distribution |
| 1188820112 | Length 1.50 in | In distribution | |
| 8881200318 | Needle Gauge,21,Gauge; | 100 | In distribution |
| 1188827112 | Length 1.50 in | In distribution | |
| 8881541604 | Total Volume 6 ml | In distribution | |
| 8881250099 | Length 1 in | 100 | In distribution |
| 1188823100 | Length 1 in | In distribution | |
| 1182115 | In distribution | ||
| 8881541125 | Total Volume 12 ml | 80 | In distribution |
| 8860 | Total Volume 12 Gallon | In distribution | |
| 8970 | Total Volume 2 Gallon | In distribution | |
| 1188830340 | In distribution | ||
| 1188818100 | Length 1 in | In distribution | |
| 1183005 | In distribution | ||
| 1181815 | In distribution | ||
| 1182310 | In distribution | ||
| 8881200144 | Needle Gauge,19,Gauge; | 100 | In distribution |
| 1188819112 | Needle Gauge,19,Gauge; | In distribution | |
| 1188825058 | Needle Gauge,25,Gauge; | In distribution | |
| 8881250057 | Needle Gauge,18,Gauge; | 100 | In distribution |
| 8881225257 | 100 | In distribution | |
| 8881540120 | In distribution | ||
| 8881250107 | Length 1.50 in | 100 | In distribution |
| 1182010 | In distribution | ||
| 8881540101 | 100 | In distribution | |
| 8881200342 | Length 1 in | 100 | In distribution |
| 8881200516 | Length 0.50 in | 100 | In distribution |
| 1181915 | In distribution | ||
| 8881250016 | Needle Gauge,18,Gauge; | 100 | In distribution |
| 1182210 | In distribution | ||
| 8881250024 | Length 1.50 in | 100 | In distribution |
| 1182558 | In distribution | ||
| 1182215 | In distribution | ||
| 8881250289 | Needle Gauge,23,Gauge; | 100 | In distribution |
| 8967Y | Total Volume 2 Gallon | In distribution | |
| 8881250172 | Needle Gauge,21,Gauge; | 100 | In distribution |
| 8881023516 | Needle Gauge,23,Gauge; | 5,000 | In distribution |
| 8881250065 | Needle Gauge,19,Gauge; | 100 | In distribution |
| 1182510 | In distribution | ||
| 8881202017 | Length 1 in | 100 | In distribution |
| 8881250362 | Needle Gauge,27,Gauge; | 100 | In distribution |
| 8881250206 | Needle Gauge,22,Gauge; | 100 | In distribution |
| 8881216066 | Needle Gauge,22,Gauge; | 50 | In distribution |
| 1182315 | In distribution | ||
| 8881216017 | Needle Gauge,20,Gauge | 50 | In distribution |
| 1188818112 | Length 1.50 in | In distribution | |
| 8881200086 | Length 1.50 in | 100 | In distribution |
| 8881250263 | Needle Gauge,23,Gauge; | 100 | In distribution |
| 8990SA | Total Volume 2 Gallon | In distribution | |
| 8881200433 | Needle Gauge,25,Gauge; | 100 | In distribution |
| 8881200680 | Length 0.75 in | 100 | In distribution |
| 8881250149 | Length 1.50 in | 100 | In distribution |
| 8871 | Total Volume 18 Gallon | In distribution | |
| 8881250321 | Needle Gauge,26,Gauge; | 100 | In distribution |
| 8881250545 | Needle Gauge,25,Gauge; | 100 | In distribution |
| 1188822100 | Length 1 in | In distribution | |
| 8881541034 | Total Volume 3 ml | 100 | In distribution |
| 8881250255 | Length 1 in | 100 | In distribution |
| 8870 | Total Volume 18 Gallon | In distribution | |
| 1188827012 | Length 0.50 in | In distribution | |
| 8881200623 | Needle Gauge,16,Gauge; | 100 | In distribution |
| 1182515 | In distribution | ||
| 1182015 | In distribution | ||
| 8881250032 | Needle Gauge,30,Gauge; | 100 | In distribution |
| 8881200219 | Length 1 in | 100 | Withdrawn |
| 8881200011 | Needle Gauge,14,Gauge; | 100 | Withdrawn |
| 8881200508 | Needle Gauge,27,Gauge; | 100 | Withdrawn |
| 1182734 | Withdrawn | ||
| 8881250040 | Needle Gauge,18,Gauge; | 100 | Withdrawn |
| 8881200136 | Length 1.50 in | 100 | Withdrawn |
| 8881200037 | Length 1.50 in | 100 | Withdrawn |
| 8881200029 | Needle Gauge,15,Gauge; | 100 | Withdrawn |
| 8881250081 | Length 1 in | 100 | Withdrawn |
| 8881050600 | Length 0.625 in | 100 | Withdrawn |
| 8881610102 | Outer Diameter 13 mm | 100 | Withdrawn |
| 8881541067 | 50 | Withdrawn | |
| 8881250305 | Needle Gauge,25,Gauge; | 100 | Withdrawn |
| 8881200441 | Length 2 in | 100 | Withdrawn |
| 8881200714 | Needle Gauge,18,Gauge; | 100 | Withdrawn |
| 8881200672 | Needle Gauge,18,Gauge; | 100 | Withdrawn |
| 8881225110 | Length 1 in | 20 | Withdrawn |
| 8881200045 | Length 1.50 in | 100 | Withdrawn |
| 8881200326 | Needle Gauge,22,Gauge; | 100 | Withdrawn |
| 8881200755 | Needle Gauge,16,Gauge; | 100 | Withdrawn |
| 8881250222 | Length 1 in | 100 | Withdrawn |
| 8881200052 | Length 1 in | 100 | Withdrawn |
| 8881250123 | Length 1 in | 100 | Withdrawn |
| 8881200805 | Length 1 in | 100 | Withdrawn |
| 8881225115 | Length 1.5 in | 20 | Withdrawn |
| 8881200185 | Length 1.50 in | 100 | Withdrawn |
| 8881200110 | Needle Gauge,18,Gauge; | 100 | Withdrawn |
| 8881200573 | Needle Gauge,14,Gauge; | 100 | Withdrawn |
| 1181810 | Withdrawn | ||
| 8881200060 | Needle Gauge,16,Gauge; | 100 | Withdrawn |
| 8881200078 | Length 1.50 in | 100 | Withdrawn |
| 8881200169 | Needle Gauge,19,Gauge; | 100 | Withdrawn |
| 8881250230 | Length 1 in | 100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterile Single-use Syringe with Needle | Jiangxi Hongda Medical Equipment Group Ltd. | 162 |
| Tkmd | Anhui Tiankang Medical Technology Co., Ltd. | 150 |
| Reli | Myco Medical Supplies, Inc. | 149 |
| STERiJECT TM | TSK Laboratory, Japan | 140 |
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 130 |
| Monoject | Cardinal Health 200, LLC | 112 |
| Jelco | ICU Medical, Inc | 108 |
| micsafe | Jiangsu Micsafe Medical Tehcnology Co., Ltd. | 105 |
| McKesson | Mckesson Medical-Surgical Inc. | 93 |
| EasyTouch | MHC Medical Products | 82 |
| Medegen Medical products | Medegen Medical Products | 78 |
| Needle, Hypodermic, Single Lumen | Becton, Dickinson AND Company | 76 |
Showing 12 of 797. All products under Needle, Hypodermic, Single Lumen
Recalls
1 of these is 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 |
|---|---|---|---|---|
| 2021-03-16 | Class II | Environmental control | Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results. | 1,599 boxes of 100 needles |
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.