Powerheart® G3 Elite Automatic AED 9790A-19
GUDID 00812394023158
Powerheart® G3 Elite AED, Fully Automatic, Korea (No battery or pads)
CARDIAC SCIENCE CORPORATION
Non-rechargeable public automated external defibrillator| Primary Device ID | 00812394023158 |
| NIH Device Record Key | 6d53cbf3-ab16-4d44-9837-8db8d8bc067d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Powerheart® G3 Elite Automatic AED |
| Version Model Number | 9790A-19 |
| Catalog Number | 9790A-19 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 103 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812394023158 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P160033
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-09 |
| Device Publish Date | 2020-07-01 |
Devices Manufactured by CARDIAC SCIENCE CORPORATION
| 00847946046118 - Sunmed | 2021-11-01 KIT, MASK, FLEX CPAP, #4, MEDIUM ADULT / HARNESS, SINGLE |
| 00847946046125 - SunMed | 2021-11-01 KIT, MASK, FLEX CPAP, #5, LARGE ADULT / HARNESS, SINGLE |
| 00847946046132 - Sunmed | 2021-11-01 KIT, MASK, FLEX CPAP, #6, X-LARGE ADULT / HARNESS, SINGLE |
| 00847946046156 - Sunmed | 2021-11-01 MASK, FLEX CPAP, #4, MEDIUM ADULT, CASE OF 20 |
| 00847946046163 - Sunmed | 2021-11-01 MASK, FLEX CPAP, #5, LARGE ADULT, CASE OF 20 |
| 00847946046170 - Sunmed | 2021-11-01 MASK, FLEX CPAP, #6, X-LARGE ADULT, CASE OF 20 |
| 00847946046187 - Powerheart® G5 Electrodes | 2021-08-26 ELECTRODES, ADULT, G5 AED |
| 00847946046194 - Powerheart® G5 Electrodes | 2021-08-26 ELECTRODES WITH CPR DEVICE, ADULT, G5 AED |
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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