Duns Number:122612547
Device Description: VICKS COOL MIST HUMIDIFIER, WHITE, JUVI VERSION
Catalog Number
-
Brand Name
Vicks
Version/Model Number
VUL520WJUV
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KFZ
Product Code Name
Humidifier, Non-Direct Patient Interface (Home-Use)
Public Device Record Key
0cd1ca87-be51-49af-b891-93d346a4b951
Public Version Date
May 27, 2020
Public Version Number
2
DI Record Publish Date
August 01, 2018
Package DI Number
70328785705200
Quantity per Package
2
Contains DI Package
00328785705201
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 | 97 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |