Catalog Number

97402-000005

Brand Name

LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors

Version/Model Number

97402

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 07, 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

a5fd897a-98cf-4222-b307-182273e29dec

Public Version Date

May 09, 2019

Public Version Number

3

DI Record Publish Date

November 05, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-