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 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 ID: 10851383003143
• NIH Device Record Key: fa74aaa1-b5bf-4971-95ce-89b482261da4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vashe Wound Solution 475 ml (16 fl oz) Flip Top Cap Container
• Version Model Number: 00314
• Catalog Number: 00314
• Company DUNS: 052758618
• Company Name: URGO MEDICAL NORTH AMERICA, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com

Device Dimensions

• Total Volume: 475 Milliliter
• Total Volume: 475 Milliliter
• Total Volume: 475 Milliliter
• Total Volume: 475 Milliliter
• Total Volume: 475 Milliliter
• Total Volume: 475 Milliliter
• Total Volume: 475 Milliliter
• Total Volume: 475 Milliliter
• Total Volume: 475 Milliliter
• Total Volume: 475 Milliliter
• Total Volume: 475 Milliliter
• Total Volume: 475 Milliliter
• Total Volume: 475 Milliliter
• Total Volume: 475 Milliliter
• Total Volume: 475 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight and heat
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight and heat
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight and heat
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight and heat
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight and heat
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight and heat
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight and heat
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight and heat
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight and heat
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight and heat
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight and heat
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight and heat
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight and heat
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight and heat
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851383003146 [Primary]
GS1	10851383003143 [Package]; Contains: 00851383003146; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131848

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-11
• Device Publish Date: 2020-02-03

Devices Manufactured by URGO MEDICAL NORTH AMERICA, LLC

• 10190769004054 - Vashe Wound Solution OTC: 2021-12-15 Vashe® Wound Solution OTC is a wound cleansing solution that is intended for cleansing, irrigating, debriding dermal wounds in
• 10190769085961 - Resta Silver Gel Bellows Bottle: 2021-12-15 Resta SilverGel is a crystal-clear antimicrobial silver gel indicated for the management of minor bums, superficial cuts, lacera
• 00190769085971 - Resta Silver Gel Tube: 2021-12-15 Resta SilverGel is a crystal-clear antimicrobial silver gel indicated for the management of minor bums, superficial cuts, lacera
• 10851383003174 - Vashe Wound Solution 475 ml (16 fl oz) Instillation Container: 2020-04-09 Vashe Wound solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption
• 10851383003228 - Vashe Wound Solution 1 L (34 fl oz) Flip Top Container: 2020-04-09 Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption
• 10851383003235 - Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container: 2020-04-09 Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption
• 00190769532451 - URGOK2 Lite (Short) Kit: 2020-02-20 URGOK2 Lite is a two layer Compression System which includes KTECH Lite: a white, short-stretch bandage; providing compression,
• 10190769532465 - URGOK2 Lite (Long) Kit: 2020-02-20 URGOK2 Lite is a two layer system including KTECH Lite: a white, short-stretch bandage; providing compression, protection and a