Duns Number:052758618
Device Description: Vashe Wound Solution is a skin, wound, burn cleansing solution that is to be used for debr 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.
Catalog Number
00314
Brand Name
Vashe Wound Solution 475 ml (16 fl oz) Flip Top Cap Container
Version/Model Number
00314
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K131848,K131848
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
fa74aaa1-b5bf-4971-95ce-89b482261da4
Public Version Date
May 19, 2020
Public Version Number
2
DI Record Publish Date
February 03, 2020
Package DI Number
10851383003143
Quantity per Package
12
Contains DI Package
00851383003146
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 12 |