Catalog Number

20550

Brand Name

Kendall

Version/Model Number

20550

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

DRO

Product Code Name

Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

Public Device Record Key

6f6a91af-e6b6-4aca-8365-2f6e2b355dfa

Public Version Date

October 07, 2021

Public Version Number

8

DI Record Publish Date

September 18, 2014

Package DI Number

10884527015580

Quantity per Package

5

Contains DI Package

20884527015587

Package Discontinue Date

July 01, 2023

Package Status

In Commercial Distribution

Package Type

-