Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container 00323

GUDID 10851383003235

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.

URGO MEDICAL NORTH AMERICA, LLC

Antimicrobial wound irrigation solution, non-sterile
Primary Device ID10851383003235
NIH Device Record Key36658af0-567e-4066-941a-46b3e3d45d39
Commercial Distribution StatusIn Commercial Distribution
Brand NameVashe Wound Solution 1 L (34 fl oz) Instillation Cap Container
Version Model Number00323
Catalog Number00323
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 Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and temperature.
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 direct sunlight and temperature.
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 direct sunlight and temperature.
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 direct sunlight and temperature.
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 direct sunlight and temperature.
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 direct sunlight and temperature.
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 direct sunlight and temperature.
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 direct sunlight and temperature.
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 direct sunlight and temperature.
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 direct sunlight and temperature.
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 direct sunlight and temperature.
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 direct sunlight and temperature.
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 direct sunlight and temperature.
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 direct sunlight and temperature.
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
GS100851383003238 [Primary]
GS110851383003235 [Package]
Contains: 00851383003238
Package: Case [6 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 Date2020-04-09
Device Publish Date2020-04-01

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