Catalog Number

40000013

Brand Name

Kendall

Version/Model Number

40000013

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 01, 2023

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

DRX

Product Code Name

Electrode, electrocardiograph

Public Device Record Key

714a70cc-eb59-4495-a2a2-928d8a663a00

Public Version Date

October 08, 2020

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

10884527008285

Quantity per Package

1000

Contains DI Package

20884527008282

Package Discontinue Date

July 01, 2023

Package Status

In Commercial Distribution

Package Type

CASE