FDA.reportPublic FDA data

AED Manager, V.2.0.5.0 Powerheart G5

Primary DI
00812394020539
Brand
AED Manager, V.2.0.5.0 Powerheart G5
Company
Cardiac Science Corporation
Model
XAEDMGR01C
Catalog number
XAEDMGR01C
Device description
Event Reporting and Administrative AED Configuration Software V 2 0 5 0 for Powerheart G5
Published
2015-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00812394020539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812394020539008123940205398123940205390812394020539

GMDN Terms#

Term, Definition table
TermDefinition
External defibrillator application softwareAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a defibrillator intended for external use on the thorax so that it may function according to its intended purpose. A basic set of applications programs and routines are included with the defibrillator and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
190713797
Device count
1
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
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

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Primary DI, Brand, Company table
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10812394027276RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
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10847946001435PEDI PADZZoll Medical CorporationMKJ2026-02-12
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10847946023345ONESTEPZoll Medical CorporationMKJ2026-02-12
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