Catalog Number

RP-BPM003

Brand Name

RENPHO BLOOD PRESSURE MONITOR

Version/Model Number

RP-BPM003

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

9e25f183-8b3b-4cd1-a858-f21bd2763339

Public Version Date

April 13, 2020

Public Version Number

1

DI Record Publish Date

April 03, 2020

Package DI Number

10860002249640

Quantity per Package

12

Contains DI Package

00860002249643

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-