FDA.reportPublic FDA data

Powerheart® AED G3 Plus Automatic AED

Primary DI
00812394020232
Brand
Powerheart® AED G3 Plus Automatic AED
Company
Cardiac Science Corporation
Model
9390A-1001
Catalog number
9390A-1001
Device description
G3Plus, AED, Automatic ,AHA 2010, with adult pads and battery
Published
2014-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MKJAutomated External Defibrillators (Non-Wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102496000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102496000POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUSCardiac Science Corporation2011-06-09MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812394020232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812394020232008123940202328123940202320812394020232

GMDN Terms#

Term, Definition table
TermDefinition
Non-rechargeable public automated external defibrillatorA portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it automatically activates defibrillation of the heart through application of electrical shocks to the chest surface. The device is placed in conspicuous public locations and is intended to be applied to the patient by a layperson. It consists of an external pulse generator (EPG) with a cardiac rhythm recognition system and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it also includes a non-rechargeable battery for energy.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure57 KiloPascal103 KiloPascal
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Atmospheric Pressure57 KiloPascal103 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1.262.953.3500techsupport@cardiacscience.com

Regulatory Flags#

DUNS number
190713797
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812394020102Powerheart® Adult Defibrillation Pads9131-0012014-09-29
00812394020126Intellisense Adult Defibrillation Pads, Powerheart® G5XELAED001AXELAED001A2015-04-29
00812394020249Powerheart® Polarized Adult Defibrillation Pads9660-0019660-0012014-09-29
00812394020492Intellisense Adult Defibrillation Pads, Powerheart® G5XELAED001BXELAED001B2015-12-18
00812394020522Intellisense Adult Defibrillation Pads, CPR Device, Powerheart® G5XELAED002AXELAED002A2015-12-21
00812394020584Powerheart® Polarized Adult Defibrillation Pads2019199-0082019199-0082015-07-24
00812394020591Powerheart® Adult Defibrillation Pads2019199-0022019199-0022015-07-24
00812394020416Powerheart AED G3 Pro ECG Monitoring Cable5111-0015111-0012017-02-09
00812394020171Intellisense™ Pediatric Defibrillation Pads Powerheart® G5XELAED003AXELAED003A2015-04-29
00812394020256Powerheart®Pediatric Pads9730-0029730-0022014-09-29
00812394020515Intellisense™ Pediatric Defibrillation Pads Powerheart® G5XELAED003BXELAED003B2015-12-18
00812394020607Powerheart®Pediatric Pads2019199-0032019199-0032015-07-24
00812394020041Powerheart® G5 Semi Automatic AEDG5S-01P0G5S-01P02015-01-01
00812394020133Intellisense® Battery Powerheart® G5XBTAED001AXBTAED001A2015-04-29
00812394020140Powerheart® G5 Semi Automatic AEDG5S-01AG5S-01A2015-01-01
00812394020157Powerheart® G5 Automatic AEDG5A-01AG5A-01A2015-01-01
00812394020164Powerheart® G5 Automatic AED G5A-01P0G5A-01P02015-01-01
00812394020331Powerheart® AED G3 Plus Automatic AED9390A-019390A-012014-09-29
00812394020362Powerheart® AED G3 Plus Automatic AED9390A-1001-SUNY9390A-1001-SUNY2014-09-29
00812394020379Powerheart® AED G3 Plus Automatic AED9390A-1001-TSO9390A-1001-TSO2014-09-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10812394027276RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
00883873031902LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
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00197644380145AED Battery ExchangeAED BATTERY EXCHANGE, LLCMKJ2026-04-15
00810149098291R&D Batteries, Inc.R & D Batteries, Inc.MKJ2026-04-01
10847946001435PEDI PADZZoll Medical CorporationMKJ2026-02-12
10847946016231ONESTEPZoll Medical CorporationMKJ2026-02-12
10847946023345ONESTEPZoll Medical CorporationMKJ2026-02-12
07613327673197LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673227LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673234LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673241LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673258LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673265LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673357LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327681864LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
00810149098208R&D Batteries, Inc.R & D Batteries, Inc.MKJ2025-11-19
00883873760482BATTERY, LI-ION, WITH IFU, LP35PHYSIO-CONTROL, INC.MKJ2025-09-26
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00883873761557LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2024-09-04
00883873761564LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2024-09-04
00883873761571LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2024-09-04