Catalog Number

-

Brand Name

FEP001

Version/Model Number

Disposable ECG-EMG electrode

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

75dabfe1-75bf-40cb-8b3a-40699780bbaf

Public Version Date

October 25, 2019

Public Version Number

1

DI Record Publish Date

October 17, 2019

Package DI Number

00857398006509

Quantity per Package

5

Contains DI Package

10857398006490

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-