Water plus Microfiber Wipe, Texwipe

Basic Information

• Brand Name: Water plus Microfiber Wipe, Texwipe
• Primary DI: 00843356100815
• Version / Model: CW150
• Company Name: CYGNUS MEDICAL L.L.C.
• Labeler DUNS: 103169095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2023-04-30
• Public Version: 1
• Public Version Date: 2023-05-08
• Public Version Status: New
• Public Device Record Key: 59d5fc91-2e7d-4708-b6d0-4a5f8dfd7187

Device Description

Water plus Microfiber Wipe, Texwipe, 7" x 8" pre-saturated wipers - 5 wipers per package, 150 packages per case (750 wipers per case).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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
FRL	Fiber, Medical, Absorbent	General Hospital	880.5300	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
Package	10843356100812	GS1		150	In Commercial Distribution
Primary	00843356100815	GS1
Unit of Use	30843356100816	GS1