cardiacscience.comPowerheart® G3 Pro AED
Cardiac Science Corporation
CARDIAC SCIENCE CORPORATION
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2112020 | 2112020 | CARDIAC SCIENCE CORPORATION | 1 | N | 2020-04-25 | 500 Burdick Pkwy DEERFIELD WI US 53531 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00812394020126 | Intellisense Adult Defibrillation Pads, Powerheart® G5 - Intellisense Adult defibrillation Pads, non-polarized for Powerheart® G5 | +1.262.953.3500 | techsupport@cardiacscience.com |
| 00812394020416 | Powerheart AED G3 Pro ECG Monitoring Cable - ECG patient monitoring cable (AHA) for Powerheart® AED G3 Pro | +1.262.953.3500 | techsupport@cardiacscience.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 4798 | 1827222149 | P160034 | Powerheart® AED G3 Pro | MKJ | 2018-12-06 |
| 4798 | 1159720045 | P160033 | Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3 | MKJ | 2018-12-07 |
| 4798 | 1024754883 | ||||
| 4798 | 1344956356 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MKJ | 2 | 2018-12-07 |
PMA#
Powerheart® G3, G3 Plus and G5 AEDs
CARDIAC SCIENCE CORPORATION
Powerheart G5 Automated External Defibrillator
CARDIAC SCIENCE CORPORATION
Powerheart G5 AED
CARDIAC SCIENCE CORPORATION
Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3
CARDIAC SCIENCE CORPORATION
Powerheart® AED G3 Pro
Cardiac Science Corporation
PMN#
Powerheart G5 AED
CARDIAC SCIENCE CORPORATION
POWERHEART G5 AED
CARDIAC SCIENCE CORPORATION
MYSENSE HEART
CARDIAC SCIENCE CORPORATION
POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS
CARDIAC SCIENCE CORPORATION
CARECENTER MD
CARDIAC SCIENCE CORPORATION
POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A
CARDIAC SCIENCE CORPORATION
9131 DEFIBRILLATION ELECTRODES
CARDIAC SCIENCE CORPORATION
Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S
CARDIAC SCIENCE CORPORATION
MODIFICATION TO POWERHEART ECD
CARDIAC SCIENCE CORPORATION
ATRIA 3100, ATRIA 6100
CARDIAC SCIENCE CORPORATION
GUDID#
Powerheart® Adult Defibrillation Pads - Defibrillation Pads(adult) with two-year shelf life for full range of Powerheart® AEDs
2014-09-29
Intellisense Adult Defibrillation Pads, Powerheart® G5 - Intellisense Adult defibrillation Pads, non-polarized for Powerheart® G5
2015-04-29
Powerheart® Polarized Adult Defibrillation Pads - Polarized Defibrillation Pads(adult) with two-year shelf life
2014-09-29
Intellisense Adult Defibrillation Pads, Powerheart® G5 - Intellisense Adult defibrillation Pads, non-polarized for Powerheart® G5
2015-12-18
Intellisense Adult Defibrillation Pads, CPR Device, Powerheart® G5 - Intellisense Adult defibrillation Pads, non-polarized, with CPR Feedback Device for Powerheart® G5
2015-12-21
Powerheart® Polarized Adult Defibrillation Pads - Polarized Defibrillation Pads(adult) with two-year shelf life under GE part number
2015-07-24
Powerheart® Adult Defibrillation Pads - Defibrillation Pads(adult) with two-year shelf life for full range of Powerheart® AEDs, under GE part number
2015-07-24
Powerheart AED G3 Pro ECG Monitoring Cable - ECG patient monitoring cable (AHA) for Powerheart® AED G3 Pro
2017-02-09
Intellisense™ Pediatric Defibrillation Pads Powerheart® G5 - Intellisense Pediatric Defibrillation Pads, reduced energy, for Powerheart G5 (up to 8 years of age or 55 lbs)
2015-04-29
Powerheart®Pediatric Pads - Pediatric defibrillation pads with two-year shelf life
2014-09-29
Intellisense™ Pediatric Defibrillation Pads Powerheart® G5 - Intellisense Pediatric Defibrillation Pads, reduced energy, for Powerheart G5 (up to 8 years of age or 55 lbs)
2015-12-18
Powerheart®Pediatric Pads - Pediatric defibrillation pads with two-year shelf life under GE part number
2015-07-24
Powerheart® G5 Semi Automatic AED - Powerheart® G5 Semi-Automatic AED
2015-01-01
Intellisense® Battery Powerheart® G5 - Intellisense non-rechargeable battery for Powerheart G5 AED with 4 year full replacement guarantee.
2015-04-29
Powerheart® G5 Semi Automatic AED - Powerheart® G5 Semi Automatic AED. Package includes: Powerheart® G5 Semi Automatic AED, battery, set of adult defirillation pads and AED manager
2015-01-01
Powerheart® G5 Automatic AED - Powerheart® G5 Automatic AED. Package includes: Powerheart® G5 Automatic AED, battery, set of adult defibrillation pads and AED manager
2015-01-01
Powerheart® G5 Automatic AED - G5A-01P0
2015-01-01
Powerheart® AED G3 Plus Automatic AED - G3Plus, AED, Automatic ,AHA 2010, with adult pads and battery
2014-09-29
Powerheart® AED G3 Plus Automatic AED - G3 Plus, AED, Automatic, AHA 2010
2014-09-29
Powerheart® AED G3 Plus Automatic AED - G3Plus, AED, Automatic, AHA 2010, with adult pads and battery
2014-09-29
Powerheart® AED G3 Plus Automatic AED - G3Plus, AED, Automatic, AHA 2010, with adult pads and TSO battery
2014-09-29
AED Manager, V.2.0.5.0 Powerheart G5 - Event Reporting and Administrative AED Configuration Software V 2 0 5 0 for Powerheart G5
2015-04-30
Powerheart G5 Kit, Semi, US Eng/ESP LA - Powerheart G5 AED, Semi Automatic, Dual Language (English/Spanish),no battery or pads
2015-04-29
Powerheart® AED G3 Pro - G3, AED, PRO ,AHA 2010
2014-09-25
Powerheart® AED G3 Automatic AED - G3, AED, Automatic, AHA 2010, TSO with adult pads and TSO battery
2014-09-29
Powerheart® AED G3 Semi Automatic AED - G3, AED, Semi-Automatic ,AHA 2010, TSO with adult pads and TSO battery
2014-09-29
Powerheart® G3 Pro Rechargeable Battery - Rechargeable battery: For Powerheart® AED G3 Pro model 9300P with 1 year full replacement guarantee
2014-09-29
Powerheart® G3 Pro Battery Charger - Charger, for rechargeable battery: Powerheart® AED G3 Pro model 9300P
2014-09-29
Powerheart® Pro Battery - 9145-301
2014-09-29
AED Manager, Powerheart G5 - Event Reporting and Administrative AED Configuration Software V.2.1.0.6 for Powerheart G5
2015-04-29
Powerheart® AED G3 Automatic AED - G3, AED, Automatic, AHA 2010
2014-09-29
Powerheart® AED G3 Semi-Automatic AED - G3, AED, Semi-Automatic, AHA 2010
2014-09-29
Powerheart® AED G3 Pro AED - G3, AED, PRO ,AHA 2010 with adult pads and battery
2014-09-29
Powerheart® AED G3 Plus Semi Automatic AED - G3Plus, AED, Semi Automatic, AHA 2010, with adult pads and battery
2014-09-29
Powerheart® G3 Battery - IntelliSense lithium battery: For Powerheart AED G3 model 9300E shipped before April 12, 2004. with 3 year full replacement guarantee
2014-09-29
FirstSave AED Battery - IntelliSense lithium battery for FirstSave AED G3 with 1 year full replacement guarantee
2014-09-30
Powerheart® G3 Battery - IntelliSense lithium battery (white): For Powerheart AED G3 model 9300E and 9300A shipped after April 12, 2004 with 4 year full replacement guarantee
2014-09-30
Powerheart® G3 Battery - IntelliSense lithium battery (yellow): For Powerheart AED G3 model 9300 A/E and 9390 A/E shipped after April 12, 2004 with 4 year full replacement guarantee.
2014-09-30
Powerheart® G3 TSO Battery - IntelliSense lithium battery: For all Cardiac Science AEDs excluding the AED G3 Pro. TSO-C142A certified with 2 year full replacement guarantee.
2014-09-30
Cardiovive AT AED Battery - IntelliSense lithium battery for Cardiovive AT AED with 4 year warranty
2014-09-30