| Primary Device ID | 00840682109666 |
| NIH Device Record Key | cd4ea8d4-cdf7-4597-a8de-8cb9054876f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CARESCAPE Central Station |
| Version Model Number | V2 Integrated MAI 700 |
| 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 |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1075 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1075 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1075 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1075 KiloPascal |