Powerheart G5 Kit, Auto, US Eng/ESP LA G5A-80C

GUDID 00812394021208

Powerheart G5 AED, Fully Automatic, Dual Language (English/Spanish), with Intellisense Adult Pads with CPR feedback device and Battery

CARDIAC SCIENCE CORPORATION

Non-rechargeable public automated external defibrillator
Primary Device ID00812394021208
NIH Device Record Key9e8fa1fe-9d1b-43a3-ab8b-ec360f18048d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowerheart G5 Kit, Auto, US Eng/ESP LA
Version Model NumberG5A-80C
Catalog NumberG5A-80C
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
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 TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100812394021208 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2017-02-15

On-Brand Devices [Powerheart G5 Kit, Auto, US Eng/ESP LA]

00812394021208Powerheart G5 AED, Fully Automatic, Dual Language (English/Spanish), with Intellisense Adult Pad
00812394021192Powerheart G5 AED, Fully Automatic, Dual Language (English/Spanish), with Intellisense Adult Pad
00812394020577Powerheart G5 AED, Fully Automatic, Dual Language (English/Spanish),no battery or pads
00812394020546Powerheart G5 AED, Fully Automatic, Dual Language (English/Spanish),with Intellisense Adult Pads

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