Duns Number:079389709
Device Description: 6-in-1 Multi-functional ThermometerInfrared Ear/Forehead Thermometer intended for the inte 6-in-1 Multi-functional ThermometerInfrared Ear/Forehead Thermometer intended for the intermittent measurement of human body temperature by people of all ages. Device is reusable and for home use only.
Catalog Number
793.86
Brand Name
Silvercrest
Version/Model Number
IAN: 326954_1901
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
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
67146b3f-99cc-416f-afb3-3596a59e1514
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
August 19, 2019
Package DI Number
14056232708200
Quantity per Package
5
Contains DI Package
04056232708203
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |