Catalog Number

HC-WC-01

Brand Name

HeartCheck CardiBeat

Version/Model Number

HC-WC-01

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

K181310

Product Code

DXH

Product Code Name

Transmitters And Receivers, Electrocardiograph, Telephone

Public Device Record Key

18162933-d85a-4567-960f-00dfd32d36bd

Public Version Date

March 12, 2019

Public Version Number

1

DI Record Publish Date

March 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-