Catalog Number

0315M/FANT

Brand Name

ECG Electrodes

Version/Model Number

0315M/FANT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 22, 2022

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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"

Yes

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

DRX

Product Code Name

Electrode, electrocardiograph

Public Device Record Key

51e0dd21-76c0-4c4b-8cf5-2f23f45f5291

Public Version Date

April 22, 2022

Public Version Number

4

DI Record Publish Date

September 26, 2016

Package DI Number

05707480133376

Quantity per Package

5

Contains DI Package

05707480133369

Package Discontinue Date

April 22, 2022

Package Status

Not in Commercial Distribution

Package Type

-