Duns Number:054318779
Device Description: No-touch forehead thermometer with fast 1 second measurement and high temperature notifica No-touch forehead thermometer with fast 1 second measurement and high temperature notification. 25 memory reading.
Catalog Number
ET720
Brand Name
No-Touch Forehead Thermometer
Version/Model Number
ET720
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
K121428,K121428
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
f34522b3-f211-4bd9-81d4-a8571ad292e1
Public Version Date
September 09, 2021
Public Version Number
1
DI Record Publish Date
September 01, 2021
Package DI Number
10073796507203
Quantity per Package
10
Contains DI Package
00073796507206
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |