AccessGUDID - DEVICE: Vashe Wound Solution OTC (00190769004057)

GUDID

Device Identifier (DI) Information

Brand Name: Vashe Wound Solution OTC
Version or Model: 00405
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00405
Company Name: URGO MEDICAL NORTH AMERICA, LLC

Primary DI Number: 00190769004057
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052758618 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 250 Milliliter

Device Record Status

Public Device Record Key: 8d5841cd-ef54-4b4b-b02b-eee95ed7a6aa
Public Version Date: November 28, 2022
Public Version Number: 2
DI Record Publish Date: December 07, 2021