Duns Number:065183758
Device Description: TFY Rapid Read Underarm Thermometer
Catalog Number
-
Brand Name
The First Years
Version/Model Number
Y7051
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
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
f1b25101-c135-4a77-94ff-ec0df939f813
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 27, 2017
Package DI Number
B268Y70514
Quantity per Package
4
Contains DI Package
B268Y70516
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 10 |