Catalog Number

-

Brand Name

Adhesive Solid Gel Electrodes (pack of 100)

Version/Model Number

Z-5000-1920

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

K030073,K030073,K030073,K030073

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

44823e47-9322-457c-a3c7-25ffcb2b1da1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

50857175006093

Quantity per Package

10

Contains DI Package

40857175006096

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner case of 1000