CaviWipes

Basic Information

• Brand Name: CaviWipes
• Primary DI: 00615375005033
• Version / Model: 13-1224
• Company Name: METREX RESEARCH, LLC
• Labeler DUNS: 145963778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 45
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 3
• Public Version Date: 2019-05-23
• Public Version Status: Update
• Public Device Record Key: 2450349c-1b4b-4ea2-ac7d-6f5a795d855c

Device Description

Disinfecting Towelettes Flatpack of PreSaturated Towelettes

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
LRJ	Disinfectant, medical devices	General Hospital	880.6890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58077	Medical device cleaning/disinfection wipe	A moist, pre-treated fabric intended to be used to wipe the surface of medical devices and equipment to clean and/or destroy harmful microorganisms or inhibit their activity. The fabric is impregnated with a solution that may include a detergent(s) for cleaning surfaces and/or a disinfectant agent(s) or a precursor compound that forms a disinfectant agent when activated (e.g., by a separate solution). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H97113122413	HIBCC
Primary	00615375005033	GS1
Unit of Use	00615375007754	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Each Flatpack Net Contents 12.6 oz. Towelette Dimension 7 x 9

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool place