Duns Number:537208717
Device Description: ri-thermo® sensioPRO / ri-thermo® sensioPRO+ non-contact thermometer is intended for the i ri-thermo® sensioPRO / ri-thermo® sensioPRO+ non-contact thermometer is intended for the intermittent measurement and monitoring of human body temperature from the forehead. The device is intended for use of all ages for professional use by one with a good understanding of the operation instruction.
Catalog Number
1840
Brand Name
Non-contact Thermometer without Bluetooth:
Version/Model Number
1840
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)
-
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
817466c5-1430-4394-a402-4e301907ce03
Public Version Date
February 05, 2021
Public Version Number
1
DI Record Publish Date
January 28, 2021
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 | 282 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 332 |