Duns Number:221516566
Device Description: A digital thermometer that measures body temperature orally, rectally or under the arm. It A digital thermometer that measures body temperature orally, rectally or under the arm. It has a plastic exterior, a metal sensing tip and a battery-powered LCD screen which displays results to 2 decimal places. It comes with a plastic protective case.
Catalog Number
-
Brand Name
The Fitness Family
Version/Model Number
002
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2017
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
-
Product Code Name
-
Public Device Record Key
b278a28f-ea6d-4ba2-a5df-e665988049bc
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 13, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |