Intellisense Adult Defibrillation Pads, Powerheart® G5 XELAED001B

GUDID 00812394020959

Intellisense Adult defibrillation Pads, non-polarized, for Powerheart® G5

CARDIAC SCIENCE CORPORATION

External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use
Primary Device ID00812394020959
NIH Device Record Keyc086cf94-7b4d-46b5-8dac-2ae3df75ac25
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntellisense Adult Defibrillation Pads, Powerheart® G5
Version Model NumberXELAED001B
Catalog NumberXELAED001B
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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Phone+1.262.953.3500
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Phone+1.262.953.3500
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Phone+1.262.953.3500
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Phone+1.262.953.3500
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Phone+1.262.953.3500
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Phone+1.262.953.3500
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Phone+1.262.953.3500
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Phone+1.262.953.3500
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Phone+1.262.953.3500
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Phone+1.262.953.3500
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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
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Phone+1.262.953.3500
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Phone+1.262.953.3500
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Phone+1.262.953.3500
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Phone+1.262.953.3500
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Phone+1.262.953.3500
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Phone+1.262.953.3500
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Phone+1.262.953.3500
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Phone+1.262.953.3500
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Phone+1.262.953.3500
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Phone+1.262.953.3500
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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
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Operating and Storage Conditions

Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
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Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
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Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
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Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
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Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
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Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
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Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
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Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
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Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
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Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
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Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
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Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
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Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
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Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
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Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
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Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
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Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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Device Identifiers

Device Issuing AgencyDevice ID
GS100812394020492 [Previous]
GS100812394020959 [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 Date2017-02-10

On-Brand Devices [Intellisense Adult Defibrillation Pads, Powerheart® G5]

00812394020959Intellisense Adult defibrillation Pads, non-polarized, for Powerheart® G5
00812394020942Intellisense Adult defibrillation Pads, non-polarized, for Powerheart® G5
00812394020492Intellisense Adult defibrillation Pads, non-polarized for Powerheart® G5
00812394020126Intellisense Adult defibrillation Pads, non-polarized for Powerheart® G5

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