Duns Number:658023275
Device Description: The NT19 thermometer is designed for the intermittent measurement of the human body's temp The NT19 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 Non-Contact Infrared Thermometer
Version/Model Number
NT19
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
9b5b2682-d74c-41d0-b41c-9eea079d12ef
Public Version Date
May 25, 2020
Public Version Number
1
DI Record Publish Date
May 15, 2020
Package DI Number
04710953421604
Quantity per Package
40
Contains DI Package
04710953421598
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 |