Duns Number:122612547
Device Description: Thermometer, Rectal, Baby
Catalog Number
-
Brand Name
Vicks
Version/Model Number
V934-V
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
K851146,K851146,K851146
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
d68694c5-53a2-4ef2-a2bc-59a217fa0a16
Public Version Date
May 27, 2020
Public Version Number
4
DI Record Publish Date
September 09, 2016
Package DI Number
10328785000440
Quantity per Package
12
Contains DI Package
00328785000443
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 |