I-Series Washers
I5 Washer Disinfector w/ single automated door 35.5"W x 33"D x 79"H, hot, cold and fil rinse water, 2 chemical pumps, integrated dryer, drain cool down, 4 level rack, Selectable…
I5 Washer Disinfector w/ single automated door 35.5″W x 33″D x 79″H, hot, cold and fil rinse water, 2 chemical pumps, integrated dryer, drain cool down, 4 level rack, Selectable Steam/Electric, 208V
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 | Skytron, LLC, United States |
|---|---|
| FDA product code | MEC |
| Device type | Disinfector, Medical Devices |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6992 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-19 |
| Record revised | 2023-10-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I5-5LR | In distribution | |
| I5-TCD | In distribution | |
| I3-DCD | In distribution | |
| I5-PT-SE | In distribution | |
| I5-PRS | In distribution | |
| I5-PRCS | In distribution | |
| I5-2LR | In distribution | |
| I5-4LR | In distribution | |
| I5-S-SE | In distribution | |
| I5-S-E | In distribution | |
| I5-RIKB | In distribution | |
| I3-TC | In distribution | |
| I3-CP | In distribution | |
| I3-PR | In distribution | |
| I5-PRSS | In distribution | |
| I5-APR | In distribution | |
| I5-TC | In distribution | |
| I5-CP | In distribution | |
| I5-CON | In distribution | |
| I5-PT | In distribution | |
| I5-3LR | In distribution | |
| I5-PT-E | In distribution | |
| I5-S | In distribution | |
| I5-RIB | In distribution | |
| I5-MIS | In distribution | |
| I3-MIS | In distribution |
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 |
| Sterling C2000 | Skytron, LLC | 25 |
| Vision | Corporation Steris Canada | 25 |
| Reliance Vision | Corporation Steris Canada | 24 |
| 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
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.