Duns Number:492177197
Device Description: DMT-489 BLACK Digital Thermometer its a forehead and ear Fever measurement
Catalog Number
-
Brand Name
iProven
Version/Model Number
DMT-489 BLACK
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
c66c8e5c-f85c-40b2-bc7f-1649cf353dc0
Public Version Date
May 23, 2022
Public Version Number
3
DI Record Publish Date
December 11, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |