Duns Number:080939375
Device Description: Forehead and Ear Infrared Thermometer - Upgraded Firmware
Catalog Number
-
Brand Name
KONQUEST
Version/Model Number
KDT-2106 V2
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172795
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
63048ad0-098e-4f98-82c4-ad4ceb7a9c81
Public Version Date
May 23, 2022
Public Version Number
3
DI Record Publish Date
November 01, 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. | 9 |