Stericycle
8 Gallon Yellow Chemotherapy Container With Gasketed Dual Purpose LID
18manufacturers in China registered for this device type
10catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (8), Jiangsu (3), Shanghai (3). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| JIE GAO Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Dongguan Yee Hing Foon Plastic Co., Ltd. / Hope Come International | Dongguan | Guangdong | Contract manufacturer | 4 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Jiangsu WLD Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 50 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Wenzhou Caretek Medical Device Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 30 |
| Unisource Shanghai Ltd. | Shanghai | Shanghai | Reprocessor | 23 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 18. All 18 manufacturers in China registered for Container, Sharps
Record
| Listed by | Bemis Manufacturing Co., United States |
|---|---|
| FDA product code | MMK |
| Device type | Container, Sharps |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K953797 |
| Record published | 2016-09-24 |
| Record revised | 2023-08-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Sizes | Total volume 2 to 8 Gallon; total volume 1 to 5 Quart |
| Distribution end date | 2018-07-11 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 175SRCL 030 | Total Volume 5 Quart | 32 | Withdrawn |
| 303SRCL 030 | Total Volume 3 Gallon | 12 | Withdrawn |
| 333SRCL 030 | Total Volume 3 Gallon | 12 | Withdrawn |
| 208SRCL 040 | Total Volume 8 Gallon | 10 | Withdrawn |
| 100SRCL 030 | Total Volume 1 Quart | 100 | Withdrawn |
| 125SRCL 030 | Total Volume 3 Quart | 24 | Withdrawn |
| 150SRCL 030 | Total Volume 5 Quart | 24 | Withdrawn |
| 108SRCL 030 | Total Volume 8 Gallon | 10 | Withdrawn |
| 111SRCL 030 | Total Volume 8 Gallon | 6 | Withdrawn |
| 102SRCL 030 | Total Volume 2 Gallon | 30 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| APmedical | ABM Italia SPA | 91 |
| Monoject | Cardinal Health | 62 |
| Vermed | Graphic Controls Acquisition Corporation | 52 |
| SharpSafety | Cardinal Health | 37 |
| Mauser Wiva 4 | Envirotain, LLC | 36 |
| Medegen Medical Products | Medegen Medical Products | 32 |
| SharpsTank | Rehrig Pacific Company | 29 |
| Medline | Medline Industries, Inc. | 27 |
| Monoject | Cardinal Health 200, LLC | 24 |
| Daniels | Daniels Corporation International PTY Ltd | 24 |
| Oak Ridge Products | Oakridge Products, LLC | 21 |
| Curaplex | Bound Tree Medical, LLC | 20 |
Showing 12 of 96. All products under Container, Sharps
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Bemis Health Care | 510(k) number | 2006-08-23 | Not classified | Other | The 5 Quart Wall Safes are shipped as two pieces (bottom & top) that customers are unable to assemble because of excess warp in the back wall of the container. | 145,656 Units | 2007-01-04 |
| Bemis Manufacturing Co. | 510(k) number | 2004-02-25 | Not classified | Other | The closure flap of the recalled sharps containers have two tabs that fit into slots on the cover for final closure and locking but some of the covers have one of the tabs that will not fit into the designated slot because the slot is occlu | 1920 containers | 2004-06-24 |
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.