Duns Number:658023275
Device Description: The IR Thermometer is intended to be used as the intermittent measurement of human body te The IR Thermometer is intended to be used as the intermittent measurement of human body temperature for people of all ages.
Catalog Number
-
Brand Name
TekCare Green-Type Infrared Thermometer
Version/Model Number
NT1G
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
129b40d3-5169-4263-8d80-d936da415dde
Public Version Date
December 09, 2019
Public Version Number
1
DI Record Publish Date
November 29, 2019
Package DI Number
04710953421475
Quantity per Package
40
Contains DI Package
04710953421468
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 |