Duns Number:122612547
Device Description: COMBO PACK - This Kit contains - 6 each of Vicks Retail Thermometers GTIN/UDI Numbers 0032 COMBO PACK - This Kit contains - 6 each of Vicks Retail Thermometers GTIN/UDI Numbers 00328785000061 and 00328785000276
Catalog Number
-
Brand Name
Vicks
Version/Model Number
V912V966CS12IC
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
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
bec95dae-e323-43e2-a308-fca78a103b86
Public Version Date
October 26, 2020
Public Version Number
5
DI Record Publish Date
November 15, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |