revyve Antimicrobial Skin and Wound Cleanser

Basic Information

• Brand Name: revyve Antimicrobial Skin and Wound Cleanser
• Primary DI: 00628451217732
• Version / Model: CWC118R
• Company Name: Kane Biotech Inc
• Labeler DUNS: 201759276
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-06
• Public Version: 1
• Public Version Date: 2026-03-16
• Public Version Status: New
• Public Device Record Key: 013a872b-c4a4-4ab5-a046-1e331288051a

Device Description

revyve® Antimicrobial Skin and Wound Cleanser helps with the mechanical removal of foreign material, exudate including dirt, debris and microorganisms from skin and wound.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
59522	Wound hydrogel dressing, antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628451217732	GS1

Premarket Submissions

Submission Number	Supplement Number
K252759	000