Duns Number:116902485
Device Description: The Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System is digital monitors The Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System is digital monitors intended for use in measuring blood pressure. The device can be used to detect irregular heartbeat. It is intended for adult indoor use only
Catalog Number
-
Brand Name
Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System
Version/Model Number
1168-05
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
a93b384a-5fcc-4293-b3a2-fcd50ac5f019
Public Version Date
June 28, 2022
Public Version Number
3
DI Record Publish Date
August 09, 2021
Package DI Number
00850033352016
Quantity per Package
10
Contains DI Package
00850033352009
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |