Duns Number:445878788
Device Description: Infrared non contact thermometer intended for the intermittent measurement of human body t Infrared non contact thermometer intended for the intermittent measurement of human body temperature in people of all ages
Catalog Number
06480
Brand Name
Tecnimed - 3J MEDICAL SUPPLIES Inc
Version/Model Number
VisioFocus PRO
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
K122412,K122412
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
1596cb27-fbb5-4c8c-bcbb-c25eb6c786c7
Public Version Date
December 04, 2020
Public Version Number
3
DI Record Publish Date
September 10, 2019
Package DI Number
00182097000573
Quantity per Package
50
Contains DI Package
00182097000443
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 |