Catalog Number

31319315

Brand Name

Kendall

Version/Model Number

31319315

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

c3250fbb-772c-4d8f-88e1-8ef33ae40f2c

Public Version Date

October 12, 2020

Public Version Number

7

DI Record Publish Date

September 18, 2014

Package DI Number

10884527020577

Quantity per Package

10

Contains DI Package

20884527020574

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-