Catalog Number

9390A-01

Brand Name

Powerheart® AED G3 Plus Automatic AED

Version/Model Number

9390A-01

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"

-

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

P160033

Product Code

MKJ

Product Code Name

Automated External Defibrillators (Non-Wearable)

Public Device Record Key

a5018561-9304-4e86-b931-826c220df43a

Public Version Date

February 08, 2022

Public Version Number

2

DI Record Publish Date

December 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-