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 table
CodeName
FEBAccessories, Cleaning, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEBAccessories, Cleaning, For EndoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010835241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010835241008600108352418600108352410860010835241

GMDN Terms#

Term, Definition table
TermDefinition
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 table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius60 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
215 364 1477info@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 table
Primary DIBrandModelCatalogPublished
00860010835265Wassenburg Transport Cart TC-6TC-62024-04-23
STORAGECABINET20000Storage Cabinet200002021-09-07
SYSTEM83PLUS9SYSTEM 83 PLUSSYSTEM 83 PLUS 92016-09-25
DRY320DRY320DRY3202023-10-31
G434SC200001Storage Cabinet20000E001882023-07-27
G434FLUSHINGSINKMODELS6Scope Assist Flushing Sink (SAFS)S62023-08-11
G434FLUSHINGSINKMODELS8Scope Assist Flushing Sink (SAFS)S82023-08-11
SYSTEM83PLUS2SYSTEM 83 PLUSSYSTEM 83 PLUS 22016-09-25
FLUSHINGSINKMODELS6Scope Assist Flushing Sink (SAFS)S62017-05-16
FLUSHINGSINKMODELS8Scope Assist Flushing Sink (SAFS)S82017-05-16
00860010835203Storage Cabinet200002024-04-23
00860010835210Scope Assist Flushing Sink (SAFS)S62024-04-23
00860010835227Scope Assist Flushing Sink (SAFS)S82024-04-23
00860010835234DRY320DRY3202024-04-23
G434DRY320DRY320DRY3202023-10-31
G434SYSTEM83PLUS2SYSTEM 83 PLUSSYSTEM 83 PLUS 22023-08-15
G434SYSTEM83PLUS9SYSTEM 83 PLUSSYSTEM 83 PLUS 92023-08-11
G434TC61Wassenburg® Transport Cart TC-6TC-62023-07-06
PPS83S6Pre-Processing Sink83-S62017-10-31
PPS83S8Pre-Processing Sink83-S8 2017-10-31

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