Duns Number:658023275
Device Description: The device is a arm type blood pressure monitor intended for automatically measures systol The device is a arm type blood pressure monitor intended for automatically measures systolic and diastolic blood pressure and pulse rate by the oscillometric method. The measurement position is at the arm.The cuff circumference is limited to 220 mm - 420 mm (approx.:9 - 17 inches).The device is intended for home use. When the device detects irregular heart beats during measurement, an irregular heartbeat symbol will appear along with the measured readings
Catalog Number
-
Brand Name
Blood pressure monitor
Version/Model Number
BPA-O300
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
a7622e3c-6c74-4958-98e9-fa0afcfc0476
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
August 12, 2018
Package DI Number
04710953421192
Quantity per Package
24
Contains DI Package
04710953421161
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cardboard box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |