Catalog Number

-

Brand Name

Covidien ECG Leads

Version/Model Number

RM-33134

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

5aec0be3-06a1-45bb-80d9-f55c4ee02194

Public Version Date

August 02, 2019

Public Version Number

4

DI Record Publish Date

June 30, 2017

Package DI Number

10816317023383

Quantity per Package

10

Contains DI Package

00816317023386

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE