Duns Number:663488544
Device Description: MOVE 78 Cold & Flu Kit comprises of a Touchless Infrared thermometer and a pulse oximeter. MOVE 78 Cold & Flu Kit comprises of a Touchless Infrared thermometer and a pulse oximeter. Both devices are bluetooth enabled.
Catalog Number
-
Brand Name
MOVE 78 Cold & Flu Kit
Version/Model Number
MOVE78-ESS
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
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
c47ba21a-e4aa-480e-b7e7-d9629002fd26
Public Version Date
January 26, 2022
Public Version Number
1
DI Record Publish Date
January 18, 2022
Package DI Number
10850031915050
Quantity per Package
1
Contains DI Package
00850031915053
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |