PREMIX CONCENTRADO (4 Liter RB38)

GUDID 10810929041643

Enzymatic detergents used to clean medical instruments.

Ruhof Corporation

Medical device cleaning agent

• Primary Device ID: 10810929041643
• NIH Device Record Key: 1a23ccc8-ea04-41d3-89ca-46c8fdffdd82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREMIX CONCENTRADO (4 Liter RB38)
• Version Model Number: 34556-29
• 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	00810929041646 [Primary]
GS1	10810929041643 [Package]; Contains: 00810929041646; 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

• 10810929045627 - ENDOZIME BIO-CLEAN NP(4 Liter RB38): 2025-09-30 Enzymatic detergents used to clean medical instruments.
• 00810929011410 - ENDOZIME INSTRUSPONGE 4mm (FLEXIBLE): 2025-07-21 brushes to clean medical instrumnets
• 00810929011281 - ENDOZIME INSTRUSPONGE 1mm (RIGID): 2025-07-18 brushes to clean medical instrument.
• 00810929011298 - ENDOZIME INSTRUSPONGE 1.5mm (RIGID): 2025-07-18 BRUSHES FOR CLEANING OF MEDICAL INSTRUMENTS
• 00810929011519 - ENDOZIME INSTRUSPONGE 1.75mm (RIGID): 2025-07-18 brushes to clean medical instrument
• 00810929011311 - ENDOZIME INSTRUSPONGE 3mm (RIGID): 2025-07-18 brushes to clean medical instruments
• 00810929011526 - ENDOZIME INSTRUSPONGE 5mm (RIGID): 2025-07-18 brushes to clean the medical instrumnets
• 00810929011335 - ENDOZIME INSTRUSPONGE 7mm (RIGID): 2025-07-18 brushes to clean medical instruments.