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System 83 Revolve

FDA UDI

Class II (US FDA UDI)

by Wassenburg Medical, Inc.

Identity

Trade Name
System 83 Revolve FDA UDI
Generic Name
Endoscope washer-disinfector (chemical) FDA UDI
Device Name
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 FDA UDI
Model / Reference
System 83 Revolve FDA UDI
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 FDA UDI

Identifiers

Primary DI / UDI-DI
00860010835241 FDA UDI
FDA Product Code
FEB FDA UDI
GMDN Term
Endoscope washer-disinfector (chemical) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Endoscope washer-disinfector (chemical)

System 83 Revolve by Wassenburg Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope washer-disinfector (chemical).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wassenburg Medical, Inc.

Sources (1)

  • FDA UDI b3ccab7f-2fa9-4433-b2a6-a7e46ef20c95 35 fields · synced May 29, 2026