Catalog Number

31319281

Brand Name

Kendall

Version/Model Number

31319281

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

4ec17600-ce49-49a1-9de8-36887f6e44c3

Public Version Date

July 02, 2021

Public Version Number

7

DI Record Publish Date

September 18, 2014

Package DI Number

10884527008421

Quantity per Package

10

Contains DI Package

20884527008428

Package Discontinue Date

July 02, 2021

Package Status

Not in Commercial Distribution

Package Type

-