Duns Number:830437997
Device Description: SmartHeart Premium Automatic Wrist Digital Blood Pressure Monitor
Catalog Number
-
Brand Name
Veridian
Version/Model Number
01-523
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
-
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
8a938d25-6645-434b-a5c9-18c3d699d2f3
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
September 11, 2017
Package DI Number
10845717007273
Quantity per Package
12
Contains DI Package
30845717007277
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 127 |