Duns Number:122612547
Device Description: VICKS WATERLESS PLUGIN PEG
Catalog Number
-
Brand Name
Vicks
Version/Model Number
V1750JUVPG
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
f11eef90-6bad-4322-80a5-a65d3001c46b
Public Version Date
May 27, 2020
Public Version Number
2
DI Record Publish Date
August 31, 2018
Package DI Number
50328785217501
Quantity per Package
24
Contains DI Package
00328785217506
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
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 |