Duns Number:691722987
Device Description: Digital Blood Pressure Monitor.
Catalog Number
UA-651BLE, UA-651CNBLE
Brand Name
A&D Medical
Version/Model Number
UA-651BLE
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
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
bcedc402-b740-466d-8ca6-d9e87851e293
Public Version Date
July 31, 2020
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
10093764603324
Quantity per Package
10
Contains DI Package
00093764603327
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. | 45 |