Catalog Number

-

Brand Name

Epatch Electrode-patch

Version/Model Number

390-0230-02

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

IKD

Product Code Name

Cable, Electrode

Public Device Record Key

09cb1d6a-e06d-462a-b110-919f37ac2f67

Public Version Date

August 21, 2020

Public Version Number

3

DI Record Publish Date

October 04, 2019

Package DI Number

B146EPE21

Quantity per Package

40

Contains DI Package

B146EPE20

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box