Catalog Number

-

Brand Name

Narcotrend Electrode

Version/Model Number

EE-0203

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

17e1ad2b-227d-4d01-b2fe-d2b83a70b73a

Public Version Date

March 26, 2019

Public Version Number

2

DI Record Publish Date

May 15, 2018

Package DI Number

04260497026013

Quantity per Package

10

Contains DI Package

04260497026006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-