Catalog Number

MDS611503AG

Brand Name

Medline

Version/Model Number

MDS611503AG

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K020003

Product Code

DRX

Product Code Name

Electrode, electrocardiograph

Public Device Record Key

fd2649c7-c33a-4649-9be7-a9e240369bfd

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

February 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-