Powerheart® AED G3 Automatic AED - G3, AED, Automatic, AHA 2010, TSO with adult pads - Cardiac Science Corporation

Duns Number:190713797

Device Description: G3, AED, Automatic, AHA 2010, TSO with adult pads and TSO battery

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More Product Details

Catalog Number

9300A-1001-TSO

Brand Name

Powerheart® AED G3 Automatic AED

Version/Model Number

9300A-1001-TSO

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

MKJ

Product Code Name

Automated External Defibrillators (Non-Wearable)

Device Record Status

Public Device Record Key

a85ddf8c-4793-49f5-97eb-5c347e93392f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 29, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARDIAC SCIENCE CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1
3 A medical device with high risk that requires premarket approval 54