Powerheart® G5 TSO Kit, Auto, US EN/LA ESP, CPRD G5A-80C-TSO
GUDID 00812394021406
Powerheart® G5 AED, Automatic (US English/LA Spanish) with Intellisense Adult Electrodes with CPR Device and TSO Battery
CARDIAC SCIENCE CORPORATION
Non-rechargeable public automated external defibrillator| Primary Device ID | 00812394021406 |
| NIH Device Record Key | 17dfae5b-66c4-46da-9ebb-f9eddc7e2361 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Powerheart® G5 TSO Kit, Auto, US EN/LA ESP, CPRD |
| Version Model Number | G5A-80C-TSO |
| Catalog Number | G5A-80C-TSO |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| 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
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812394021406 [Primary] |
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 | 2019-04-08 |
| Device Publish Date | 2019-03-29 |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.