Catalog Number

BP8000-M

Brand Name

Heart Guide Wrist Blood Pressure Monitor

Version/Model Number

BP8000-M

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

K182481,K182481,K182481

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

48844e4f-ff8d-4649-8687-00036501fda8

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

December 19, 2018

Package DI Number

20073796268002

Quantity per Package

4

Contains DI Package

10073796268005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case