Catalog Number

-

Brand Name

Covidien ECG Leads

Version/Model Number

RM-33135

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"

-

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

IKD

Product Code Name

Cable, Electrode

Public Device Record Key

c3524139-628b-4a1c-85ad-ab591dc74c4d

Public Version Date

August 02, 2019

Public Version Number

4

DI Record Publish Date

August 23, 2016

Package DI Number

10816317020627

Quantity per Package

5

Contains DI Package

00816317020620

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE