Vashe Wound Solution 475 ml (16 fl oz) Flip Top Cap Container 00314

GUDID 10851383003143

Vashe Wound Solution is a skin, wound, burn cleansing solution that is to be used for debridmement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 475 ml (16 fl oz) container size with a flip top cap.

URGO MEDICAL NORTH AMERICA, LLC

Antimicrobial wound irrigation solution, non-sterile
Primary Device ID10851383003143
NIH Device Record Keyfa74aaa1-b5bf-4971-95ce-89b482261da4
Commercial Distribution StatusIn Commercial Distribution
Brand NameVashe Wound Solution 475 ml (16 fl oz) Flip Top Cap Container
Version Model Number00314
Catalog Number00314
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
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 Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter
Total Volume475 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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 *Store away from 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
GS100851383003146 [Primary]
GS110851383003143 [Package]
Contains: 00851383003146
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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