FDA.reportPublic FDA data

Powerheart® AED G3 Plus Semi Automatic AED

Primary DI
00812394020225
Brand
Powerheart® AED G3 Plus Semi Automatic AED
Company
Cardiac Science Corporation
Model
9390E-1001
Catalog number
9390E-1001
Device description
G3Plus, AED, Semi 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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812394020225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812394020225008123940202258123940202250812394020225

GMDN Terms#

Term, Definition table
TermDefinition
Non-rechargeable public semi-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 audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. It is placed in conspicuous public locations and is intended to be operated by a layperson. It consists of two skin-adhesive, cartridge-type, disposable electrodes containing non-rechargeable batteries that provide the shock energy, and an electrode-regulating external pulse generator (EPG), which may include a CPR feedback.

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

Regulatory Flags#

DUNS number
190713797
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
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
00812394020232Powerheart® AED G3 Plus Automatic AED9390A-10019390A-10012014-09-29
00812394020331Powerheart® AED G3 Plus Automatic AED9390A-019390A-012014-09-29
00812394020362Powerheart® AED G3 Plus Automatic AED9390A-1001-SUNY9390A-1001-SUNY2014-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10847946001435PEDI PADZZoll Medical CorporationMKJ2026-02-12
10847946016231ONESTEPZoll Medical CorporationMKJ2026-02-12
10847946023345ONESTEPZoll Medical CorporationMKJ2026-02-12
00810149098208R&D Batteries, Inc.R & D Batteries, Inc.MKJ2025-11-19
20192253017516KendallCardinal Health 200, LLCMKJ2024-02-28
20192253017530KendallCardinal Health 200, LLCMKJ2024-02-28
20192253017561Medi-Trace CadenceCardinal Health 200, LLCMKJ2024-02-28
20192253017608Medi-Trace CadenceCardinal Health 200, LLCMKJ2024-02-28
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10653405046813CONMEDConmed CorporationMKJ2023-10-19
20192253017714KendallCardinal Health 200, LLCMKJ2023-06-15
10884838002859HeartStartPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-02-25
10884838002842HeartStart Adult/Child Plus PadsPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-01-06
10884838002866HeartStartPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-01-06
10884838022048Adult/Child Pre-Connect Defib PadPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-01-06
20192253017554Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-08-19
20192253017622Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-08-19
20192253018865Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-08-19
20192253017578Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253017585Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253017639Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
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20192253018889Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253017547Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-28
20192253017295KendallCardinal Health 200, LLCMKJ2021-05-06
20192253017455KendallCardinal Health 200, LLCMKJ2021-05-05
20192253017721KendallCardinal Health 200, LLCMKJ2021-05-05
20192253017745KendallCardinal Health 200, LLCMKJ2021-05-05