Vashe Wound Solution 250 ml (8.5 fl oz) Flip Top Cap 00313

GUDID 00851383003139

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 250 ml (8.5 fl oz) size with a flip top cap.

URGO MEDICAL NORTH AMERICA, LLC

Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution
Primary Device ID00851383003139
NIH Device Record Key3fc3c4b6-79ab-4623-98a8-d41e6ba6c4cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameVashe Wound Solution 250 ml (8.5 fl oz) Flip Top Cap
Version Model Number00313
Catalog Number00313
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-Counterfalse

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
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 Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight and heat.
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100851383003139 [Primary]
GS110851383003136 [Package]
Package: Case [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 Date2020-02-11
Device Publish Date2020-02-03

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