Catalog Number

989803179031

Brand Name

MR Patient Care Single Patch ECG Electrodes (25)

Version/Model Number

QUADTRODE MRI ECG PAD,25/BOX

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

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

DPS

Product Code Name

ELECTROCARDIOGRAPH

Public Device Record Key

4a55c2ee-251e-43e8-bd98-4611f788fe59

Public Version Date

March 01, 2022

Public Version Number

5

DI Record Publish Date

August 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-