Vashe Wound Solution OTC 00405

GUDID 10190769004054

Vashe® Wound Solution OTC is a wound cleansing solution that is intended for cleansing, irrigating, debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. Vashe® Wound Solution OTC is intended for OTC use for management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.

URGO MEDICAL NORTH AMERICA, LLC

Antimicrobial wound irrigation solution, non-sterile
Primary Device ID10190769004054
NIH Device Record Key8d5841cd-ef54-4b4b-b02b-eee95ed7a6aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameVashe Wound Solution OTC
Version Model Number00405
Catalog Number00405
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 Perscriptionfalse
OTC Over-The-Countertrue

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

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
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

Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from direct sunlight and heat. Close cap tightly after each use.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100190769004057 [Primary]
GS110190769004054 [Package]
Contains: 00190769004057
Package: Case [12 Units]
In Commercial Distribution

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 Date2021-12-15
Device Publish Date2021-12-07

Devices Manufactured by URGO MEDICAL NORTH AMERICA, LLC

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