Duns Number:054318779
Device Description: Omron automatic digital upper arm blood pressure monitor. Two users with 60 readings of m Omron automatic digital upper arm blood pressure monitor. Two users with 60 readings of memory storage per user. Bluetooth connectivity.
Catalog Number
BP5350
Brand Name
Omron Gold Upper Arm Blood Pressure Monitor
Version/Model Number
BP5350
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
K133379,K133379
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
2f4b9e11-33c8-4839-872e-94d9a3456f2d
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
July 01, 2019
Package DI Number
10073796265356
Quantity per Package
10
Contains DI Package
00073796265359
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |