Duns Number:054318779
Device Description: Upper arm blood pressure monitor with Bluetooth connectivity, 2 users and 100 readings per Upper arm blood pressure monitor with Bluetooth connectivity, 2 users and 100 readings per user featuring TruRead.
Catalog Number
BP7450
Brand Name
Omron 10 Series Connected Upper Arm Blood Pressure Monitor
Version/Model Number
BP7450
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,K133383
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
6b2c7e19-fcfa-4579-aace-2737f2610014
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
May 15, 2019
Package DI Number
10073796267459
Quantity per Package
10
Contains DI Package
00073796267452
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 |