Vashe Antimicrobial Wound Gel 118 mL Laminate Tube - Flip Top Cap

Basic Information

• Brand Name: Vashe Antimicrobial Wound Gel 118 mL Laminate Tube - Flip Top Cap
• Primary DI: 00851383003634
• Version / Model: 00360
• Company Name: URGO MEDICAL NORTH AMERICA, LLC
• Labeler DUNS: 052758618
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-17
• Public Version: 1
• Public Version Date: 2025-11-25
• Public Version Status: New
• Public Device Record Key: 5940b100-5265-45fd-bb5b-d665195aa25f

Device Description

Vashe® Antimicrobial Wound Gel is an aqueous gel that aids in the removal of foreign objects such as dirt and debris from granulating wounds and forms a protective barrier that provides for a moist wound environment which loosens contaminated exudate, slough and other foreign materials within the wound bed. A moist wound environment is also supportive of the healing process by aiding autolytic debridement.The hypochlorous acid in Vashe Antimicrobial Wound Gel acts as a preservative to kill and inhibit growth of microorganisms in the bottle and on gauze or cover dressings.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• 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	00851383003634	GS1
Package	10851383003631	GS1	Flip Cap	12	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141863	000

Device Sizes

Type	Value	Unit	Text
Total Volume	118	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature, between 5 °C (41 °F) and 25 °C (77 °F), away from direct sunlight and heat.
• Type: Handling Environment Temperature
• Temperature Range: 32 – 122 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius