Vashe Wound Solution OTC

Basic Information

• Brand Name: Vashe Wound Solution OTC
• Primary DI: 00190769004057
• Version / Model: 00405
• Catalog Number: 00405
• 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: 2021-12-07
• Public Version: 2
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 8d5841cd-ef54-4b4b-b02b-eee95ed7a6aa

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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	10190769004054	GS1	Case	12	In Commercial Distribution
Primary	00190769004057	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	250	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store away from direct sunlight and heat. Close cap tightly after each use.
• Type: Storage Environment Temperature
• Temperature Range: 41 – 77 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 32 – 122 Degrees Fahrenheit