revyve Antimicrobial Wound Gel

Basic Information

• Brand Name: revyve Antimicrobial Wound Gel
• Primary DI: 00628451217701
• Version / Model: CWG030R
• Company Name: Kane Biotech Inc
• Labeler DUNS: 201759276
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-11
• Public Version: 3
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: 2fd5d077-eb5e-40b7-8a53-3bea30f03628

Device Description

A white, odourless hydrogel that provides a moist wound environment conducive to wound healing. The gel provides preservative properties through an antimicrobial (PHMB) to help inhibit microbial colonization within the gel during shelf storage. Chronic wounds are known to contain non-viable tissue. The gel can facilitate debridement through a moist wound environment.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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
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	00628451217701	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K223259	000

Device Sizes

Type	Value	Unit	Text
Weight	28	Gram