Primary Device ID | 00812394021413 |
NIH Device Record Key | 838b5665-9b34-4ef2-abdf-8659d76f7562 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Powerheart® G5 TSO Kit, Semi, US EN/LA ESP |
Version Model Number | G5S-80A-TSO |
Catalog Number | G5S-80A-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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00812394021413 [Primary] |
MKJ | Automated External Defibrillators (Non-Wearable) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-04-08 |
Device Publish Date | 2019-03-29 |
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 |
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 |