Catalog Number

6000-ECG5A

Brand Name

Matrix Mini ECG Module Kit

Version/Model Number

6000-ECG5A

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

DSI

Product Code Name

Detector And Alarm, Arrhythmia

Public Device Record Key

8fb164a7-d5ed-49d8-a4ec-8ce1f572f2da

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-