Catalog Number

11403-000001

Brand Name

CHARGE-PAK™ Charging Unit & 2 QUIK-PAK Electrodes

Version/Model Number

11403

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Yes

Prescription Use (Rx)

-

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

e6e6b921-ca3a-47ce-acf8-6606781a1755

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 10, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-