Vashe Wound Solution 250 ml (8.5 fl oz) Instillation Cap Container

Basic Information

• Brand Name: Vashe Wound Solution 250 ml (8.5 fl oz) Instillation Cap Container
• Primary DI: 00851383003160
• Version / Model: 00316
• Catalog Number: 00316
• Company Name: URGO MEDICAL NORTH AMERICA, LLC
• Labeler DUNS: 052758618
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-07
• Public Version: 3
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 94de0463-c29a-4f53-b47c-dbdd7710e7f7

Device Description

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 an instillation cap.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
59523	Antimicrobial wound irrigation solution	A solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10851383003167	GS1	Case	12	In Commercial Distribution
Primary	00851383003160	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K131848	000

Device Sizes

Type	Value	Unit	Text
Total Volume	250	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store away from sunlight and heat.
• Type: Handling Environment Temperature
• Temperature Range: 32 – 122 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 41 – 77 Degrees Fahrenheit