Powerheart® G5 Semi Automatic AED G5S-01A

GUDID 00812394020140

Powerheart® G5 Semi Automatic AED. Package includes: Powerheart® G5 Semi Automatic AED, battery, set of adult defirillation pads and AED manager

Cardiac Science Corporation

Non-rechargeable public semi-automated external defibrillator
Primary Device ID00812394020140
NIH Device Record Key553df8d8-b7b1-4f64-b2d6-a0d327aa70f9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowerheart® G5 Semi Automatic AED
Version Model NumberG5S-01A
Catalog NumberG5S-01A
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 Kittrue
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

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 570 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 570 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 570 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 570 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 570 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 570 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100812394020140 [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 Date2015-01-01

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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