Home GUDID 00190769003548 Vashe Wipes Skin Cleansing Solution Kit
Primary DI 00190769003548
Brand Vashe Wipes Skin Cleansing Solution Kit
Company URGO MEDICAL NORTH AMERICA, LLC
Model 00354
Catalog number 00354
Device description The Vashe Wipes Skin Cleansing Solution Kit contains a bottle of Vashe Wound Solution and dry, nonwoven wipes. The user is instructed to wet the wipes with the Solution just prior to use. The Kit is intended for use in cleansing patient skin.
Published 2018-03-28
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name MAC Decontamination Kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MAC Decontamination Kit General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10190769003545 Package GS1 12 Not in Commercial Distribution 00190769003548 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10190769003545 10190769003545 00190769003548 00190769003548 190769003548 0190769003548
GMDN Terms# Term, Definition table Term Definition Non-antimicrobial wound irrigation solution, multiple solute A 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 32 Degrees Fahrenheit 100 Degrees Fahrenheit
Regulatory Flags# DUNS number 052758618 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00851383003122 Vashe Wound Solution 118 ml container - Flip Cap 00312 2019-12-02 00851383003146 Vashe Wound Solution 475 ml (16 fl oz) Flip Top Cap Container 00314 00314 2020-02-03 00851383003160 Vashe Wound Solution 250 ml (8.5 fl oz) Instillation Cap Container 00316 00316 2020-02-07 00851383003177 Vashe Wound Solution 475 ml (16 fl oz) Instillation Container 00317 00317 2020-04-01 00851383003221 Vashe Wound Solution 1 L (34 fl oz) Flip Top Container 00322 00322 2020-04-01 00851383003238 Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container 00323 00323 2020-04-01 00851383003139 Vashe Wound Solution 250 ml (8.5 fl oz) Flip Top Cap 00313 00313 2020-02-03 00851383003634 Vashe Antimicrobial Wound Gel 118 mL Laminate Tube - Flip Top Cap 00360 2025-11-17 00190769003555 Vashe Sterile Sleeve 00355 00355 2017-07-17 00190769004057 Vashe Wound Solution OTC 00405 00405 2021-12-07 00190769532437 URGOK2 553243 553243 2019-12-26 00190769532468 URGOK2 Lite 553246 553246 2019-12-20 00190769532444 URGOK2 553244 553244 2019-12-20 00190769532451 URGOK2 Lite 553245 553245 2019-12-20 00851383003528 Drawtex Hydroconductive Wound Dressing with LevaFiber Edema Wrap 00352 00352 2020-02-03 00851383003214 Drawtex Hydroconductive Wound Dressing with LevaFiber 18 X 0.39 00321 00321 2019-12-02 00851383003009 Drawtex Hydroconductive Wound Dressing with LevaFiber 2X2 00300 00300 2019-11-01 00851383003016 Drawtex Hydroconductive Wound Dressing with LevaFiber 3X3 00301 00301 2019-11-01 00851383003023 Drawtex Hydroconductive Wound Dressing with LevaFiber 4X4 00302 00302 2019-11-01 00851383003030 Drawtex Hydroconductive Wound Dressing with LevaFiber 6X8 00303 00303 2019-11-01
Other Devices Sharing Product Codes# 
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