Catalog Number

9300P-01

Brand Name

Powerheart® AED G3 Pro

Version/Model Number

9300P-01

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

-

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

K102496,K102496

Product Code

MKJ

Product Code Name

Automated External Defibrillators (Non-Wearable)

Public Device Record Key

1b399e29-d4d7-4738-9fd7-ec3cfa4888e9

Public Version Date

February 08, 2022

Public Version Number

4

DI Record Publish Date

February 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-