Powerheart G5 Auto G5A-80P1

GUDID 00812394021222

Powerheart® G5 Automatic AED, dual language(English/Spanish), no battery or pads

CARDIAC SCIENCE CORPORATION

Non-rechargeable public automated external defibrillator
Primary Device ID00812394021222
NIH Device Record Keyd9487001-7d0d-415c-bfe6-bb147d0e4fd3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowerheart G5 Auto
Version Model NumberG5A-80P1
Catalog NumberG5A-80P1
Company DUNS080355564
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone+1.262.953.3500
Emailtechsupport@cardiacscience.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100812394021222 [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 Date2017-02-15

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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