Powerheart® AED G3 Plus Automatic AED 9390A-1001

GUDID 00812394020232

G3Plus, AED, Automatic ,AHA 2010, with adult pads and battery

Cardiac Science Corporation

Non-rechargeable public automated external defibrillator
Primary Device ID00812394020232
NIH Device Record Key97f296f7-dfe6-4ccf-ac83-7f7c77b88d9d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowerheart® AED G3 Plus Automatic AED
Version Model Number9390A-1001
Catalog Number9390A-1001
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100812394020232 [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 Date2014-09-29

On-Brand Devices [Powerheart® AED G3 Plus Automatic AED]

00812394021109G3Plus, AED, Automatic, AHA 2010, with adult pads and TSO battery
00812394021086G3Plus, AED, Automatic ,AHA 2010, with adult pads and battery
00812394021079G3 Plus, AED, Automatic, AHA 2010
00812394020379G3Plus, AED, Automatic, AHA 2010, with adult pads and TSO battery
00812394020362G3Plus, AED, Automatic, AHA 2010, with adult pads and battery
00812394020331G3 Plus, AED, Automatic, AHA 2010
00812394020232G3Plus, AED, Automatic ,AHA 2010, with adult pads and battery
00812394023288G3Plus, AED, Automatic ,AHA 2010, with adult pads and battery
00812394023271G3 Plus, AED, Automatic, AHA 2010
00812394023301G3Plus, AED, Automatic, AHA 2010, with adult pads and TSO battery

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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