Catalog Number

-

Brand Name

Wrist Blood Pressure Monitor

Version/Model Number

BPM165W

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

ee806c0c-a9d3-48ed-9262-2874ac641949

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 15, 2016

Package DI Number

06944249300139

Quantity per Package

24

Contains DI Package

06944249300887

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-