Duns Number:122612547
Device Description: VICKS VAPORIZER 1.5 GL LOCKING
Catalog Number
-
Brand Name
Vicks
Version/Model Number
V150GL
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
a71be111-90f8-4997-82b1-9c6ceb2d3fb6
Public Version Date
May 27, 2020
Public Version Number
3
DI Record Publish Date
March 30, 2018
Package DI Number
20328785101502
Quantity per Package
2
Contains DI Package
00328785101508
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 |