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

GUDID 00851383003634

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.

URGO MEDICAL NORTH AMERICA, LLC

Wound hydrogel dressing, antimicrobial
Primary Device ID00851383003634
NIH Device Record Key5940b100-5265-45fd-bb5b-d665195aa25f
Commercial Distribution StatusIn Commercial Distribution
Brand NameVashe Antimicrobial Wound Gel 118 mL Laminate Tube - Flip Top Cap
Version Model Number00360
Company DUNS052758618
Company NameURGO MEDICAL NORTH AMERICA, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone855-888-8273
Emailinfo@us.urgo.com
Phone855-888-8273
Emailinfo@us.urgo.com
Phone855-888-8273
Emailinfo@us.urgo.com
Phone855-888-8273
Emailinfo@us.urgo.com
Phone855-888-8273
Emailinfo@us.urgo.com
Phone855-888-8273
Emailinfo@us.urgo.com
Phone855-888-8273
Emailinfo@us.urgo.com
Phone855-888-8273
Emailinfo@us.urgo.com
Phone855-888-8273
Emailinfo@us.urgo.com
Phone855-888-8273
Emailinfo@us.urgo.com

Device Dimensions

Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter
Total Volume118 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, between 5 °C (41 °F) and 25 °C (77 °F), away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, between 5 °C (41 °F) and 25 °C (77 °F), away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, between 5 °C (41 °F) and 25 °C (77 °F), away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, between 5 °C (41 °F) and 25 °C (77 °F), away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, between 5 °C (41 °F) and 25 °C (77 °F), away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, between 5 °C (41 °F) and 25 °C (77 °F), away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, between 5 °C (41 °F) and 25 °C (77 °F), away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, between 5 °C (41 °F) and 25 °C (77 °F), away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, between 5 °C (41 °F) and 25 °C (77 °F), away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100851383003634 [Primary]
GS110851383003631 [Package]
Package: Flip Cap [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-11-25
Device Publish Date2025-11-17

Devices Manufactured by URGO MEDICAL NORTH AMERICA, LLC

00851383003634 - Vashe Antimicrobial Wound Gel 118 mL Laminate Tube - Flip Top Cap2025-11-25Vashe® 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.
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