Duns Number:054318779
Device Description: Omron 7 Series Blood Pressure Monitor with Bluetooth
Catalog Number
BP761CANN
Brand Name
7 Series Plus Bluetooth Smart Blood Pressure Monitor
Version/Model Number
BP761CANN
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
8148bf54-bafe-4486-ae92-4c3692a938de
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
10073796761346
Quantity per Package
10
Contains DI Package
00073796761349
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 |