Compliance

Basic Information

• Brand Name: Compliance
• Primary DI: 00615375003688
• Version / Model: 10-2500
• Company Name: METREX RESEARCH, LLC
• Labeler DUNS: 145963778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 4
• Public Version Date: 2022-11-07
• Public Version Status: Update
• Public Device Record Key: 31f91b1b-37ce-478e-848e-99b90cf364f8

Device Description

Sterilizing and Disinfecting Solution 7.35% Hydrogen Peroxide

Device Characteristics

• Single Use: No
• 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: No
• 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
MED	Sterilant, medical devices	General Hospital	880.6885	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44835	Hydrogen peroxide device sterilant	A gaseous or liquid substance that includes hydrogen peroxide (H2O2) as its primary agent to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. The substance may be presented in discrete quantities to accommodate the requirements of a sterilization device or system. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615375003688	GS1
Package	10615375003685	GS1		4	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K972708	000

Device Sizes

Type	Value	Unit	Text
Total Volume	1	Gallon

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Solution should be stored in its original sealed container at room temperature 15 - 30