Catalog Number

-

Brand Name

Easy@Home Adhesive Electrodes

Version/Model Number

ETP538

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132588,K132588,K132588

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

e6a44e18-6720-460a-883e-f94e0869e11a

Public Version Date

November 26, 2018

Public Version Number

3

DI Record Publish Date

August 05, 2016

Package DI Number

00850253007239

Quantity per Package

8

Contains DI Package

00850253007178

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-