FDA.reportPublic FDA data

Powerheart® G5 Automatic AED

Primary DI
00812394020164
Brand
Powerheart® G5 Automatic AED
Company
Cardiac Science Corporation
Model
G5A-01P0
Catalog number
G5A-01P0
Device description
Powerheart® G5 Automatic AED
Published
2015-01-01
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
K122758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122758000POWERHEART G5 AEDCardiac Science Corporation2014-02-12MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812394020164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812394020164008123940201648123940201640812394020164

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
Storage Environment Atmospheric Pressure570 KiloPascal1060 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 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
Kit
true
Serial number
true
Manufacturing 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
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
00812394020379Powerheart® AED G3 Plus Automatic AED9390A-1001-TSO9390A-1001-TSO2014-09-29

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Primary DI, Brand, Company table
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10847946023345ONESTEPZoll Medical CorporationMKJ2026-02-12
00810149098208R&D Batteries, Inc.R & D Batteries, Inc.MKJ2025-11-19
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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
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