AccessGUDID - DEVICE: Vashe Wound Solution 250 ml (8.5 fl oz) Flip Top Cap (00851383003139)

GUDID

Device Identifier (DI) Information

Brand Name: Vashe Wound Solution 250 ml (8.5 fl oz) Flip Top Cap
Version or Model: 00313
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00313
Company Name: URGO MEDICAL NORTH AMERICA, LLC

Primary DI Number: 00851383003139
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 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 a flip top cap.

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):	Yes
Over the Counter (OTC):	No
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 [?]
K131848	000

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: Keep away from direct sunlight and heat.
Handling Environment Temperature: between 32 and 122 Degrees Fahrenheit
Storage Environment Temperature: between 41 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 250 Milliliter

Device Record Status

Public Device Record Key: 3fc3c4b6-79ab-4623-98a8-d41e6ba6c4cc
Public Version Date: November 28, 2022
Public Version Number: 3
DI Record Publish Date: February 03, 2020