AED Manager, V.2.0.5.0 Powerheart G5 XAEDMGR01C

GUDID 00812394020539

Event Reporting and Administrative AED Configuration Software V 2 0 5 0 for Powerheart G5

Cardiac Science Corporation

External defibrillator application software
Primary Device ID00812394020539
NIH Device Record Keyb607e94c-f25c-4ef0-a39e-e8ec8e9348e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAED Manager, V.2.0.5.0 Powerheart G5
Version Model NumberXAEDMGR01C
Catalog NumberXAEDMGR01C
Company DUNS190713797
Company NameCardiac Science Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812394020539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MKJAutomated External Defibrillators (Non-Wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-04-30

Devices Manufactured by Cardiac Science Corporation

00847946046118 - Sunmed2021-11-01 KIT, MASK, FLEX CPAP, #4, MEDIUM ADULT / HARNESS, SINGLE
00847946046125 - SunMed2021-11-01 KIT, MASK, FLEX CPAP, #5, LARGE ADULT / HARNESS, SINGLE
00847946046132 - Sunmed2021-11-01 KIT, MASK, FLEX CPAP, #6, X-LARGE ADULT / HARNESS, SINGLE
00847946046156 - Sunmed2021-11-01 MASK, FLEX CPAP, #4, MEDIUM ADULT, CASE OF 20
00847946046163 - Sunmed2021-11-01 MASK, FLEX CPAP, #5, LARGE ADULT, CASE OF 20
00847946046170 - Sunmed2021-11-01 MASK, FLEX CPAP, #6, X-LARGE ADULT, CASE OF 20
00847946046187 - Powerheart® G5 Electrodes2021-08-26 ELECTRODES, ADULT, G5 AED
00847946046194 - Powerheart® G5 Electrodes2021-08-26 ELECTRODES WITH CPR DEVICE, ADULT, G5 AED

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