Duns Number:492177197
Device Description: DMT-511GR measure baby's temperature by a quick swipe across the forehead and by ear,give DMT-511GR measure baby's temperature by a quick swipe across the forehead and by ear,give accurate measurement within a second.
Catalog Number
-
Brand Name
iProven
Version/Model Number
DMT-511GR
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
K181215
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
4e8dce50-9b30-4556-953f-3009745bcc9f
Public Version Date
October 28, 2019
Public Version Number
1
DI Record Publish Date
October 18, 2019
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 |