Catalog Number

BP100-4G

Brand Name

Qardio Pro Cellular Blood Pressure Monitor

Version/Model Number

BP100-4G

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

ed1b7e6b-54b7-4ab9-bedc-b4e801b08c44

Public Version Date

December 07, 2021

Public Version Number

1

DI Record Publish Date

November 29, 2021

Package DI Number

10854894005392

Quantity per Package

10

Contains DI Package

00854894005395

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-