Catalog Number

-

Brand Name

Universal electrode-patch

Version/Model Number

02-01609

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)

-

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

59440836-6b55-4f26-93bb-ea8b830f58ae

Public Version Date

August 21, 2020

Public Version Number

4

DI Record Publish Date

October 04, 2019

Package DI Number

B146PE21

Quantity per Package

40

Contains DI Package

B146PE20

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box