PREMIX CONCENTRADO(4 Liter FB63)

GUDID 00810929016200

Enzymatic detergents used to clean medical instruments.

Ruhof Corporation

Medical device cleaning agent

• Primary Device ID: 00810929016200
• NIH Device Record Key: 8a637843-e8c1-48a9-83ed-fd33faaa502c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREMIX CONCENTRADO(4 Liter FB63)
• Version Model Number: 34556-33
• 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

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810929016163 [Primary]
GS1	00810929016200 [Package]; Contains: 00810929016163; Package: CASE [4 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: 2025-07-03
• Device Publish Date: 2025-06-25

Devices Manufactured by Ruhof Corporation

• 00810929010192 - PREPZYME (22 ounce/650ml with foam sprayer): 2025-07-03 Enzymatic detergents used to clean medical instruments.
• 00810929011151 - PREPZYME (8.45oz/250ml with dropper): 2025-07-03 Enzymatic detergents used to clean medical instruments.
• 00810929013605 - PREPZYME (4 Liter RB38): 2025-07-03 Enzymatic detergents used to clean medical instruments.
• 00810929016200 - PREMIX CONCENTRADO(4 Liter FB63): 2025-07-03Enzymatic detergents used to clean medical instruments.
• 00810929016200 - PREMIX CONCENTRADO(4 Liter FB63): 2025-07-03 Enzymatic detergents used to clean medical instruments.
• 00810929016262 - PREPZYME (3oz/90ml bottle): 2025-07-03 Enzymatic detergents used to clean medical instruments.
• 00810929016323 - PREPZYME (10 Liter SB63): 2025-07-03 Enzymatic detergents used to clean medical instruments.
• 00810929016330 - PREPZYME (5GL/20L RP): 2025-07-03 Enzymatic detergents used to clean medical instruments.
• 00810929016354 - PREPZYME (60 Liter Drum): 2025-07-03 Enzymatic detergents used to clean medical instruments.