Duns Number:004135503
Device Description: Clever Choice Duo Ear & Forehead Thermometer - Infrared 2020
Catalog Number
CLETEF-786
Brand Name
Clever Choice
Version/Model Number
CLETEF-786
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
K181215,K181215,K181215
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
6bec2e79-848c-44c5-9eae-b26ffcce3d76
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
August 31, 2020
Package DI Number
10898302141883
Quantity per Package
50
Contains DI Package
00898302141886
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |