Duns Number:687879726
Device Description: The DT-100 non-contact infrared thermometer is intended to be used to measure temperature The DT-100 non-contact infrared thermometer is intended to be used to measure temperature for consumers including adult, pediatric and neonatal using infrared sensors. It can detect the body temperature from human's face. The DT-100 infrared thermometer can be used by consumers in household environment.
Catalog Number
00885
Brand Name
Non-contact Infrared Thermometer DT-100
Version/Model Number
DT-100
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
K160358
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
47d050f2-5fc7-4bdb-b730-f7412a2e9421
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
July 03, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 33 |