Powerheart® G5 TSO Kit, Semi, US EN/LA ESP CPRD G5S-80C-TSO

GUDID 00812394021420

Powerheart® G5 AED, Semi-Automatic (US English / LA Spanish) with Intellisense Adult Electrodes with CPR Device and TSO Battery

CARDIAC SCIENCE CORPORATION

Non-rechargeable public semi-automated external defibrillator
Primary Device ID00812394021420
NIH Device Record Keyfae68103-b555-4a8c-89f2-4963abc1d231
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowerheart® G5 TSO Kit, Semi, US EN/LA ESP CPRD
Version Model NumberG5S-80C-TSO
Catalog NumberG5S-80C-TSO
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

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling 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
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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 HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100812394021420 [Primary]

FDA Product Code

MKJAutomated External Defibrillators (Non-Wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-08
Device Publish Date2019-03-29

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

Trademark Results [Powerheart]

Mark Image

Registration | Serial
Company
Trademark
Application Date
POWERHEART
POWERHEART
78905168 3206323 Live/Registered
CARDIAC SCIENCE CORPORATION
2006-06-09
POWERHEART
POWERHEART
77687247 not registered Dead/Abandoned
Hunter Laboratories, Inc.
2009-03-10
POWERHEART
POWERHEART
74367566 1955504 Live/Registered
CARDIAC SCIENCE CORPORATION
1993-03-12

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