PREPZYME (22 ounce/650ml with foam sprayer)

Basic Information

• Brand Name: PREPZYME (22 ounce/650ml with foam sprayer)
• Primary DI: 00810929010185
• Version / Model: 34559-19
• Company Name: Ruhof Corporation
• Labeler DUNS: 082779828
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-25
• Public Version: 1
• Public Version Date: 2025-07-03
• Public Version Status: New
• Public Device Record Key: af27d2f5-19c2-4118-975e-8c8bc2482320

Device Description

Enzymatic detergents used to clean medical instruments.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	880.6150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63385	Medical device cleaning agent	A substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810929010192	GS1	CASE	24	In Commercial Distribution
Primary	00810929010185	GS1

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 40 – 130 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 40 – 130 Degrees Fahrenheit