Powerheart® G5 Electrodes
GUDID 00847946046194
ELECTRODES WITH CPR DEVICE, ADULT, G5 AED
CARDIAC SCIENCE CORPORATION
External defibrillator electrode, adult, single-use| Primary Device ID | 00847946046194 |
| NIH Device Record Key | f1b7087f-49e0-42bd-8f05-5f7490c159ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Powerheart® G5 Electrodes |
| Version Model Number | XELAED002C |
| Company DUNS | 080355564 |
| Company Name | CARDIAC SCIENCE CORPORATION |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847946046194 [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 | 2021-08-26 |
| Device Publish Date | 2021-08-18 |
On-Brand Devices [Powerheart® G5 Electrodes]
| 00847946046200 | ELECTRODES, PEDIATRIC, G5 AED |
| 00847946046194 | ELECTRODES WITH CPR DEVICE, ADULT, G5 AED |
| 00847946046187 | ELECTRODES, 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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.