Powerheart® G3 TSO Battery - IntelliSense lithium battery: For all Cardiac - Cardiac Science Corporation

Duns Number:190713797

Device Description: IntelliSense lithium battery: For all Cardiac Science AEDs excluding the AED G3 Pro. TSO-C IntelliSense lithium battery: For all Cardiac Science AEDs excluding the AED G3 Pro. TSO-C142A certified with 2 year full replacement guarantee.

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More Product Details

Catalog Number

9147-201-TSO

Brand Name

Powerheart® G3 TSO Battery

Version/Model Number

9147-201-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

12a7a1f2-609b-4013-9ed7-df0c83b4fd3d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 30, 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