Catalog Number

-

Brand Name

CardioQuick Patch

Version/Model Number

CQP-004-RT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 23, 2017

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

2bed286d-d389-474b-9a55-7479b3282d87

Public Version Date

September 08, 2021

Public Version Number

3

DI Record Publish Date

October 14, 2016

Package DI Number

00869413000218

Quantity per Package

50

Contains DI Package

00869413000201

Package Discontinue Date

May 23, 2017

Package Status

Not in Commercial Distribution

Package Type

-