Catalog Number

BP6350

Brand Name

Omron 7 Series Wrist Blood Pressure Monitor

Version/Model Number

BP6350

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

K182166,K182166

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

ac580278-22e8-468c-a0e6-fcb82bfad11b

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

April 29, 2019

Package DI Number

10073796266353

Quantity per Package

10

Contains DI Package

00073796266356

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case