FDA.reportPublic FDA data

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

Primary DI
00851383003634
Brand
Vashe Antimicrobial Wound Gel 118 mL Laminate Tube - Flip Top Cap
Company
URGO MEDICAL NORTH AMERICA, LLC
Model
00360
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 formsa protective barrier that provides for a moist wound environment which loosens contaminated exudate, slough and other foreign materials within the wound bed. Amoist 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.
Published
2025-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141863000PURICORE WOUND HYDROGEL SPRAY DRESSINGPuricore, Inc.2015-05-14FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851383003631PackageGS112In Commercial Distribution
00851383003634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085138300363110851383003631
00851383003634008513830036348513830036340851383003634

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, antimicrobialA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume118Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature32 Degrees Fahrenheit122 Degrees Fahrenheit
Special Storage Condition, Specify00Store at room temperature, between 5 °C (41 °F) and 25 °C (77 °F), away from direct sunlight and heat.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-888-8273info@us.urgo.com

Regulatory Flags#

DUNS number
052758618
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851383003122Vashe Wound Solution 118 ml container - Flip Cap003122019-12-02
00851383003146Vashe Wound Solution 475 ml (16 fl oz) Flip Top Cap Container00314003142020-02-03
00851383003160Vashe Wound Solution 250 ml (8.5 fl oz) Instillation Cap Container00316003162020-02-07
00851383003177Vashe Wound Solution 475 ml (16 fl oz) Instillation Container00317003172020-04-01
00851383003221Vashe Wound Solution 1 L (34 fl oz) Flip Top Container00322003222020-04-01
00851383003238Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container00323003232020-04-01
00851383003139Vashe Wound Solution 250 ml (8.5 fl oz) Flip Top Cap00313003132020-02-03
00190769003555Vashe Sterile Sleeve00355003552017-07-17
00190769003548Vashe Wipes Skin Cleansing Solution Kit00354003542018-03-28
00190769004057Vashe Wound Solution OTC00405004052021-12-07
00190769532437URGOK2 5532435532432019-12-26
00190769532468URGOK2 Lite 5532465532462019-12-20
00190769532444URGOK2 5532445532442019-12-20
00190769532451URGOK2 Lite 5532455532452019-12-20
00851383003528Drawtex Hydroconductive Wound Dressing with LevaFiber Edema Wrap00352003522020-02-03
00851383003214Drawtex Hydroconductive Wound Dressing with LevaFiber 18 X 0.3900321003212019-12-02
00851383003009Drawtex Hydroconductive Wound Dressing with LevaFiber 2X2 00300003002019-11-01
00851383003016Drawtex Hydroconductive Wound Dressing with LevaFiber 3X300301003012019-11-01
00851383003023Drawtex Hydroconductive Wound Dressing with LevaFiber 4X400302003022019-11-01
00851383003030Drawtex Hydroconductive Wound Dressing with LevaFiber 6X800303003032019-11-01

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