Powerheart® G5 Automatic AED G5A-01P1
GUDID 00812394021185
Powerheart® G5 Automatic AED no battery or pads
CARDIAC SCIENCE CORPORATION
Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator| Primary Device ID | 00812394021185 |
| NIH Device Record Key | 47f79587-65e3-4243-bd0f-bf829be7c6d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Powerheart® G5 Automatic AED |
| Version Model Number | G5A-01P1 |
| Catalog Number | G5A-01P1 |
| Company DUNS | 080355564 |
| Company Name | CARDIAC SCIENCE CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812394021185 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K122758
FDA Product Code
| MKJ | Automated External Defibrillators (Non-Wearable) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-15 |
On-Brand Devices [Powerheart® G5 Automatic AED]
| 00812394021185 | Powerheart® G5 Automatic AED no battery or pads |
| 00812394021161 | Powerheart G5 AED, Fully Automatic, English, with Intellisense Adult Pads with CPR feedback devi |
| 00812394021154 | Powerheart G5 AED, Fully Automatic, English, with Intellisense Adult Pads and Battery |
| 00812394020164 | Powerheart® G5 Automatic AED |
| 00812394020157 | Powerheart® G5 Automatic AED. Package includes: Powerheart® G5 Automatic AED, battery, set |
| 00812394023134 | Powerheart® G5 Automatic AED no battery or pads |
Trademark Results [Powerheart]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POWERHEART 78905168 3206323 Live/Registered |
CARDIAC SCIENCE CORPORATION 2006-06-09 |
 POWERHEART 77687247 not registered Dead/Abandoned |
Hunter Laboratories, Inc. 2009-03-10 |
 POWERHEART 74367566 1955504 Live/Registered |
CARDIAC SCIENCE CORPORATION 1993-03-12 |
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