System 83 Revolve
- Primary DI
- 00860010835241
- Brand
- System 83 Revolve
- Company
- Wassenburg Medical, Inc.
- Model
- System 83 Revolve
- Device description
- The System 83 Revolve® Endoscope Washer/Disinfector is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes utilizing a detergent and FDA cleared high-level disinfectant validated by Wassenburg Medical.The System 83 Revolve® utilizes a processing chamber and the immersion method to perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high-level disinfected endoscope. The System 83 Revolve® is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the channels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocess
- Published
- 2025-02-24
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- OTC
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| FEB | Accessories, Cleaning, For Endoscope |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FEB | Accessories, Cleaning, For Endoscope | Gastroenterology, Urology | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00860010835241 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00860010835241 | 00860010835241 | 860010835241 | 0860010835241 |
GMDN Terms#
| Term | Definition |
|---|---|
| Endoscope washer-disinfector (chemical) | An electrically-powered unit intended to be used for both washing and chemical disinfection of endoscopes, and their accessories. It has built-in features to circulate cleaning and disinfectant solutions through the lumen (flushing) of the endoscope; some types may also have built-in drying features. It is not intended for device sterilization. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Humidity | 10 Percent (%) Relative Humidity | 90 Percent (%) Relative Humidity | |
| Handling Environment Temperature | 0 Degrees Celsius | 60 Degrees Celsius | |
| Storage Environment Humidity | 10 Percent (%) Relative Humidity | 90 Percent (%) Relative Humidity | |
| Storage Environment Temperature | 0 Degrees Celsius | 60 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 215 364 1477 | info@wassenburgmedical.com |
Regulatory Flags#
- DUNS number
- 118762097
- Device count
- 1
- Serial number
- true
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00860010835265 | Wassenburg Transport Cart TC-6 | TC-6 | 2024-04-23 | |
| STORAGECABINET20000 | Storage Cabinet | 20000 | 2021-09-07 | |
| SYSTEM83PLUS9 | SYSTEM 83 PLUS | SYSTEM 83 PLUS 9 | 2016-09-25 | |
| DRY320 | DRY320 | DRY320 | 2023-10-31 | |
| G434SC200001 | Storage Cabinet | 20000 | E00188 | 2023-07-27 |
| G434FLUSHINGSINKMODELS6 | Scope Assist Flushing Sink (SAFS) | S6 | 2023-08-11 | |
| G434FLUSHINGSINKMODELS8 | Scope Assist Flushing Sink (SAFS) | S8 | 2023-08-11 | |
| SYSTEM83PLUS2 | SYSTEM 83 PLUS | SYSTEM 83 PLUS 2 | 2016-09-25 | |
| FLUSHINGSINKMODELS6 | Scope Assist Flushing Sink (SAFS) | S6 | 2017-05-16 | |
| FLUSHINGSINKMODELS8 | Scope Assist Flushing Sink (SAFS) | S8 | 2017-05-16 | |
| 00860010835203 | Storage Cabinet | 20000 | 2024-04-23 | |
| 00860010835210 | Scope Assist Flushing Sink (SAFS) | S6 | 2024-04-23 | |
| 00860010835227 | Scope Assist Flushing Sink (SAFS) | S8 | 2024-04-23 | |
| 00860010835234 | DRY320 | DRY320 | 2024-04-23 | |
| G434DRY320 | DRY320 | DRY320 | 2023-10-31 | |
| G434SYSTEM83PLUS2 | SYSTEM 83 PLUS | SYSTEM 83 PLUS 2 | 2023-08-15 | |
| G434SYSTEM83PLUS9 | SYSTEM 83 PLUS | SYSTEM 83 PLUS 9 | 2023-08-11 | |
| G434TC61 | Wassenburg® Transport Cart TC-6 | TC-6 | 2023-07-06 | |
| PPS83S6 | Pre-Processing Sink | 83-S6 | 2017-10-31 | |
| PPS83S8 | Pre-Processing Sink | 83-S8 | 2017-10-31 |
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| 10724995245969 | Rapicide PA High-Level Disinfectant | MEDIVATORS INC. | FEB | 2026-03-06 |
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| 40677964055322 | Medivators Hookup | MEDIVATORS INC. | FEB | 2025-06-10 |
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