Duns Number:054318779
Device Description: Omron automatic digital upper arm blood pressure monitor with 80 reading memory storage. B Omron automatic digital upper arm blood pressure monitor with 80 reading memory storage. Bluetooth connectivity.
Catalog Number
BP5250
Brand Name
Omron Silver Upper Arm Blood Pressure Monitor
Version/Model Number
BP5250
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
K133383
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
ae2924f8-0aec-4b22-8994-cf5aa23c4fbf
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
July 01, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |