FDA.reportPublic FDA data

Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container

Primary DI
00851383003238
Brand
Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container
Company
URGO MEDICAL NORTH AMERICA, LLC
Model
00323
Catalog number
00323
Device description
Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 1 L (34 fl oz) size with the instillation cap.
Published
2020-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K131848000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131848000VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc.2014-03-31FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851383003235PackageGS16In Commercial Distribution
00851383003238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085138300323510851383003235
00851383003238008513830032388513830032380851383003238

GMDN Terms#

Term, Definition table
TermDefinition
Non-antimicrobial wound irrigation solution, multiple soluteA solution of electrolytes sometimes with other compounds [not limited to sodium chloride (NaCl), therefore not a saline solution], intended to be used to irrigate and clean a superficial skin wound to support natural healing; it is not intended to provide antimicrobial activity. The device may be supplied in a plastic container with a spray nozzle and is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature32 Degrees Fahrenheit122 Degrees Fahrenheit
Special Storage Condition, Specify00Store away from direct sunlight and temperature.
Storage Environment Temperature41 Degrees Fahrenheit77 Degrees Fahrenheit

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
00851383003139Vashe Wound Solution 250 ml (8.5 fl oz) Flip Top Cap00313003132020-02-03
00851383003634Vashe Antimicrobial Wound Gel 118 mL Laminate Tube - Flip Top Cap003602025-11-17
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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