Catalog Number

97401-000031

Brand Name

LIFEPAK® 500 Automated External Defibrillator

Version/Model Number

97401

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 09, 2015

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

cb0ac013-b7ba-4209-a577-effa6ba85825

Public Version Date

May 30, 2019

Public Version Number

3

DI Record Publish Date

November 11, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-