Reliance Vision
The Reliance Vision Single-Chamber Washer Disinfector, Electric Unit is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware,…
The Reliance Vision Single-Chamber Washer Disinfector, Electric Unit is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments (such as forceps and clamps), theater shoes and other similar and related items found in healthcare facilities.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Medease Life Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 15 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Dongguan Yingfeng Metal & Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Aopu Lighting (Jinyun) Co., Ltd. | Lishui | Zhejiang | Contract manufacturer | 9 |
| Dongguan I-Believe Electronic Appliance Co., Ltd. | Dongguan | Guangdong | Manufacturer | 5 |
| Guangdong Eraclean Technology Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 3 |
| Xiamen Forsound Hearing Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 3 |
| Zhongshan Sunclean Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 3 |
Record
| Listed by | Corporation Steris Canada |
|---|---|
| FDA product code | MEC |
| Device type | Disinfector, Medical Devices |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6992 |
| Premarket notification | Exempt |
| Record published | 2020-09-04 |
| Record revised | 2023-11-07 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2023-11-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Multi-Chamber | In distribution | |
| Multi-Chamber | In distribution | |
| Multi-Chamber | In distribution | |
| Multi-Chamber | In distribution | |
| Multi-Chamber | In distribution | |
| Multi-Chamber | In distribution | |
| Multi-Chamber | In distribution | |
| Multi-Chamber | In distribution | |
| Multi-Chamber | In distribution | |
| Multi-Chamber | In distribution | |
| Multi-Chamber | In distribution | |
| Multi-Chamber | In distribution | |
| Multi Chamber | In distribution | |
| Multi-Chamber | In distribution | |
| Multi-Chamber | In distribution | |
| Multi-Chamber | In distribution | |
| Multi-Chamber | In distribution | |
| Multi-Chamber | In distribution | |
| Single Chamber | Withdrawn | |
| Single Chamber | Withdrawn | |
| Single Chamber | Withdrawn | |
| Single Chamber | Withdrawn | |
| Single Chamber | Withdrawn | |
| Single Chamber | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Steelco | Steelco SPA | 106 |
| Disinfector, Medical Devices | Corporation Steris Canada | 76 |
| Amsco | Corporation Steris Canada | 69 |
| Accessory | Getinge Disinfection AB | 64 |
| Sterling P1800 | Skytron, LLC | 43 |
| CleanStart | Skytron, LLC | 31 |
| I-Series Washers | Skytron, LLC | 26 |
| Sterling C2000 | Skytron, LLC | 25 |
| Vision | Corporation Steris Canada | 25 |
| Sterling Washers | Skytron, LLC | 23 |
| Disinfector, Medical Devices | Medisafe UK Ltd. | 16 |
| Getinge 46-SERIES | Getinge Disinfection AB | 12 |
Showing 12 of 96. All products under Disinfector, Medical Devices
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Steris Corporation | UDI-DI | 2023-04-10 | Class II | Nonconforming Material/Component | In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually | 322 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.