Catalog Number

Not Applicable

Brand Name

MedSource Electrodes

Version/Model Number

MS-65005-RCS

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"

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

K093327,K093327,K093327

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

1db46614-4dda-4fd0-a2cf-e52e89913c3d

Public Version Date

July 23, 2021

Public Version Number

1

DI Record Publish Date

July 15, 2021

Package DI Number

00816703028667

Quantity per Package

24

Contains DI Package

00816703028650

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box