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
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

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
Instrument non-thermal chemical disinfectorAn electrically-powered unit intended to be used for the non-thermal chemical disinfection of probes, surgical instruments, and/or endoscopes, and their accessories (e.g., heat-sensitive instruments). It may include washing features and may have built-in features to circulate cleaning and disinfectant solutions through a device lumen; 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 Humidity00
Handling Environment Temperature00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
215 364 1477info@wassenburgmedical.com

Regulatory Flags#

DUNS number
118762097
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
SYSTEM83PLUS9SYSTEM 83 PLUSSYSTEM 83 PLUS 92016-09-25
00860010835210Scope Assist Flushing Sink (SAFS)S62024-04-23
00860010835227Scope Assist Flushing Sink (SAFS)S82024-04-23
G434SYSTEM83PLUS2SYSTEM 83 PLUSSYSTEM 83 PLUS 22023-08-15
G434FLUSHINGSINKMODELS6Scope Assist Flushing Sink (SAFS)S62023-08-11
G434FLUSHINGSINKMODELS8Scope Assist Flushing Sink (SAFS)S82023-08-11
G434SYSTEM83PLUS9SYSTEM 83 PLUSSYSTEM 83 PLUS 92023-08-11
SYSTEM83PLUS2SYSTEM 83 PLUSSYSTEM 83 PLUS 22016-09-25
FLUSHINGSINKMODELS6Scope Assist Flushing Sink (SAFS)S62017-05-16
FLUSHINGSINKMODELS8Scope Assist Flushing Sink (SAFS)S82017-05-16
00860010835265Wassenburg Transport Cart TC-6TC-62024-04-23
STORAGECABINET20000Storage Cabinet200002021-09-07
DRY320DRY320DRY3202023-10-31
G434SC200001Storage Cabinet20000E001882023-07-27
00860010835203Storage Cabinet200002024-04-23
00860010835234DRY320DRY3202024-04-23
G434DRY320DRY320DRY3202023-10-31
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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