Ruhof Endozime AW Plus w/ APA (4.2oz/125ml bottle) 34521-08

GUDID 00810929014756

Enzymatic detergents used to clean medical instruments.

Ruhof Corporation

Medical device cleaning agent

• Primary Device ID: 00810929014756
• NIH Device Record Key: f0990ae5-bc0b-4b76-8174-35dabc4d5c9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ruhof Endozime AW Plus w/ APA (4.2oz/125ml bottle)
• Version Model Number: 34521-08
• Catalog Number: 34521-08
• Company DUNS: 082779828
• Company Name: Ruhof Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Dimensions

• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 130 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810929014435 [Primary]
GS1	00810929014756 [Package]; Contains: 00810929014435; Package: Case [100 Units]; In Commercial Distribution

FDA Product Code

• FLG: Cleaner, Ultrasonic, Medical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-15
• Device Publish Date: 2023-11-07

Devices Manufactured by Ruhof Corporation

• 10810929045580 - ScopeValet Guardian Disposable Endoscope Valves with Cleaning Adapter: 2024-11-19 ScopeValet Guardian Disposable Endoscope Valves with Cleaning Adapter
• 10810929044507 - AIR/WATER CLEANING VALVES: 2024-10-23 AIR/WATER CLEANING VALVES
• 00810929014756 - Ruhof Endozime AW Plus w/ APA (4.2oz/125ml bottle): 2023-11-15Enzymatic detergents used to clean medical instruments.
• 00810929014756 - Ruhof Endozime AW Plus w/ APA (4.2oz/125ml bottle): 2023-11-15 Enzymatic detergents used to clean medical instruments.
• 10810929044873 - Ruhof Scope Valet Custom Kit: 2022-06-27 Endoscopy Procedure Kit
• 10810929043739 - Ruhof Scope Valet Guardian: 2022-05-13
• 10810929019598 - Ruhof Scope Valet Guardian: 2021-11-15