CardioLab
GUDID 00840682146012
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Cardiac electrophysiology analysis system| Primary Device ID | 00840682146012 |
| NIH Device Record Key | 2567967f-6bf1-4d9c-ba5f-863c6c16e849 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CardioLab |
| Version Model Number | A1 |
| Company DUNS | 784985108 |
| Company Name | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682146012 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K130626
FDA Product Code
| DQK | Computer, diagnostic, programmable |
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 | 2019-06-19 |
| Device Publish Date | 2019-06-11 |
On-Brand Devices [CardioLab]
| 00840682146012 | A1 |
| 00840682123549 | v6.9.6 R3 |
| 00840682119689 | Simulator-Internal |
| 00840682119641 | Simulator |
| 00195278507044 | Computer CardioLab Acquisition v8.0 |
| 00195278935656 | AltiX AI.i CardioLab Computer |
Trademark Results [CardioLab]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARDIOLAB 86551008 not registered Dead/Abandoned |
Perkins, Jennifer 2015-03-03 |
 CARDIOLAB 74432391 1876478 Live/Registered |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 1993-09-07 |
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