Catalog Number

ES82417

Brand Name

Kendall

Version/Model Number

ES82417

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 11, 2021

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

4c7d869f-6860-42ed-956d-babf5c189220

Public Version Date

March 12, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

10884527004843

Quantity per Package

75

Contains DI Package

30884527004847

Package Discontinue Date

March 11, 2021

Package Status

Not in Commercial Distribution

Package Type

PACK_OR_INNER_PACK