Duns Number:445878788
Device Description: Infrared thermometer intended for intermittent measurement of human body temperature in pe Infrared thermometer intended for intermittent measurement of human body temperature in people of all ages. Measurement site: forehead (without contact).
Catalog Number
06470
Brand Name
Tecnimed - Handi-Craft Company
Version/Model Number
VisioFocus SMART
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
9721f8bf-7192-4645-ba04-16b0efffbc7d
Public Version Date
December 04, 2020
Public Version Number
5
DI Record Publish Date
June 27, 2017
Package DI Number
00182097000245
Quantity per Package
6
Contains DI Package
00182097000238
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |