Duns Number:658023275
Device Description: The NT17 THERMO DISTANCE thermometer is designed for the intermittent measurement of the h The NT17 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in the domestic environment and can be used upon people of all ages
Catalog Number
-
Brand Name
TekCare Touch Free Infrared Thermometer
Version/Model Number
NT17
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
60d81bed-6d15-463d-938b-a9050186608e
Public Version Date
April 23, 2020
Public Version Number
1
DI Record Publish Date
April 15, 2020
Package DI Number
04710953421529
Quantity per Package
40
Contains DI Package
04710953421512
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |