Catalog Number

989803149901

Brand Name

NA

Version/Model Number

989803149901

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K030509

Product Code

DRX

Product Code Name

Electrode, electrocardiograph

Public Device Record Key

cd6a3e4c-f682-4fc6-b8f1-f54bf82f4b58

Public Version Date

November 24, 2021

Public Version Number

4

DI Record Publish Date

May 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-