Catalog Number

31177705

Brand Name

Kendall

Version/Model Number

31177705

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

MKJ

Product Code Name

Automated External Defibrillators (Non-Wearable)

Public Device Record Key

3566f980-f07a-4d3f-9801-722dbda46900

Public Version Date

May 07, 2021

Public Version Number

8

DI Record Publish Date

September 18, 2014

Package DI Number

20884527005946

Quantity per Package

10

Contains DI Package

10884527005949

Package Discontinue Date

July 01, 2023

Package Status

In Commercial Distribution

Package Type

-