Duns Number:963223677
Device Description: The Thermometer can display the result in either Fahrenheit or degree Celsius. Colour - B The Thermometer can display the result in either Fahrenheit or degree Celsius. Colour - BlackHow to use:Steady and smoothly scroll the wheel either back and fourth or in one direction, so as to travel 12 inches or 30 cm. The scrolling will kinetically charge the device. Continue scroll the wheel until the LCD ON.Position the thermometer at the distance of less than 1 inch for the center of the patients eyebrows.Press and release the measure button.
Catalog Number
-
Brand Name
Ozeri
Version/Model Number
TH1-BL
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"
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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
380db6dc-44bc-4c37-8319-f39f0b741e72
Public Version Date
November 09, 2021
Public Version Number
1
DI Record Publish Date
November 01, 2021
Package DI Number
10815817014150
Quantity per Package
1
Contains DI Package
00815817014153
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Giftbox
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |