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 ID00810929014756
NIH Device Record Keyf0990ae5-bc0b-4b76-8174-35dabc4d5c9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRuhof Endozime AW Plus w/ APA (4.2oz/125ml bottle)
Version Model Number34521-08
Catalog Number34521-08
Company DUNS082779828
Company NameRuhof Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Dimensions

Total Volume125 Milliliter
Total Volume125 Milliliter
Total Volume125 Milliliter
Total Volume125 Milliliter
Total Volume125 Milliliter
Total Volume125 Milliliter
Total Volume125 Milliliter
Total Volume125 Milliliter
Total Volume125 Milliliter
Total Volume125 Milliliter
Total Volume125 Milliliter
Total Volume125 Milliliter
Total Volume125 Milliliter
Total Volume125 Milliliter
Total Volume125 Milliliter
Total Volume125 Milliliter
Total Volume125 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810929014435 [Primary]
GS100810929014756 [Package]
Contains: 00810929014435
Package: Case [100 Units]
In Commercial Distribution

FDA Product Code

FLGCleaner, Ultrasonic, Medical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-15
Device Publish Date2023-11-07

Devices Manufactured by Ruhof Corporation

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10810929044668 - OLYMPUS ENDOSCOPY KIT IV2025-02-19 OLYMPUS ENDOSCOPY KIT IV
10810929044675 - OLYMPUS ENDOSCOPY KIT V2025-02-19 OLYMPUS ENDOSCOPY KIT V
10810929045474 - OLYMPUS ENDOSCOPY KIT VI2025-02-19 OLYMPUS ENDOSCOPY KIT VI
10810929045498 - OLYMPUS ENDOSCOPY KIT VIII2025-02-19 OLYMPUS ENDOSCOPY KIT VIII
10810929045580 - ScopeValet Guardian Disposable Endoscope Valves with Cleaning Adapter2024-11-19 ScopeValet Guardian Disposable Endoscope Valves with Cleaning Adapter
10810929044507 - AIR/WATER CLEANING VALVES2024-10-23 AIR/WATER CLEANING VALVES
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