Duns Number:545301488
Device Description: The device is an Ear and forehead thermometer, which is intended to measure human body tem The device is an Ear and forehead thermometer, which is intended to measure human body temperature.
Catalog Number
-
Brand Name
Little Journey
Version/Model Number
DSO364
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
K100488,K100488
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
c6a8b8e6-cd61-4a13-8a61-2cd75b596c8e
Public Version Date
December 04, 2020
Public Version Number
5
DI Record Publish Date
October 16, 2017
Package DI Number
16926408700018
Quantity per Package
3
Contains DI Package
06926408700011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |