Catalog Number

405-HT

Brand Name

American Heart- Tech Non-Speaking Wrist BPM

Version/Model Number

KD-735

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

K150430,K150430

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

f0dadb98-d050-42b6-8ab7-226517f6b75d

Public Version Date

August 27, 2020

Public Version Number

7

DI Record Publish Date

August 22, 2016

Package DI Number

10894046001506

Quantity per Package

10

Contains DI Package

00894046001509

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

405-HT-C