Catalog Number

31115796

Brand Name

Kendall

Version/Model Number

31115796

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

2578f960-7f2b-41de-b006-35d999c37835

Public Version Date

November 20, 2020

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

20884527005885

Quantity per Package

600

Contains DI Package

10884527005888

Package Discontinue Date

July 01, 2023

Package Status

In Commercial Distribution

Package Type

CASE