Catalog Number

80403-000118

Brand Name

LIFEPAK® CR Plus and LIFEPAK Express defibrillators

Version/Model Number

80403

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2019

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

For Single-Use

-

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

41bafb64-1d32-4db4-86c1-96d7cff9f89c

Public Version Date

May 01, 2019

Public Version Number

3

DI Record Publish Date

November 10, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-