Catalog Number

DBP-2127

Brand Name

Heart Check Blood Pressure Monitor

Version/Model Number

BP-201M

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)

Yes

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

f1e27753-7cb7-4baa-bc2e-8ff1e43fc3d0

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

May 01, 2016

Package DI Number

10891237001079

Quantity per Package

48

Contains DI Package

00891237001072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case