Duns Number:421343701
Device Description: This thermometer is intended for non-contact to measurement of forehead temperature at hom This thermometer is intended for non-contact to measurement of forehead temperature at home or hospital for anyone,forehead temperature measurement is suitable for the human body, can also be used to measure surface temperature.
Catalog Number
-
Brand Name
Mothermed
Version/Model Number
IR110
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
K113761
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
a2771f87-303c-4588-bc7a-502ad79c9c93
Public Version Date
December 04, 2020
Public Version Number
4
DI Record Publish Date
January 05, 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 |
|---|---|---|
| 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. | 43 |