Duns Number:059247507
Device Description: FeverScan Ultra Reusable Forehead Thermometer
Catalog Number
BFT55U
Brand Name
FeverScan Ultra
Version/Model Number
BFT55U
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 09, 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"
Yes
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
KPD
Product Code Name
Strip, Temperature, Forehead, Liquid Crystal
Public Device Record Key
86acbff4-9b0e-4f6b-b72a-eb907004e49b
Public Version Date
February 24, 2020
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
20815236020395
Quantity per Package
5
Contains DI Package
10815236020398
Package Discontinue Date
May 09, 2017
Package Status
Not in Commercial Distribution
Package Type
Poly Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |