Catalog Number

MGLRG

Brand Name

EKG Patch™ (Large)

Version/Model Number

Large

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

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

06fce679-7028-4ed7-85fe-8accb9422ba8

Public Version Date

July 09, 2020

Public Version Number

1

DI Record Publish Date

July 01, 2020

Package DI Number

10850018485019

Quantity per Package

10

Contains DI Package

00850018485012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box