GI Genius™ Module 100
GUDID 08055060110314
LINKVERSE SRL
Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit Endoscopic video image interpretive unit| Primary Device ID | 08055060110314 |
| NIH Device Record Key | cd3880f0-6d16-4760-923d-d700a8c7e043 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GI Genius™ Module 100 |
| Version Model Number | GGM100.US |
| Company DUNS | 338806666 |
| Company Name | LINKVERSE SRL |
| 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
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 75.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08055060110314 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K233964
FDA Product Code
| QNP | Gastrointesinal Lesion Software Detection System |
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 | 2024-03-05 |
| Device Publish Date | 2024-02-26 |
Devices Manufactured by LINKVERSE SRL
| 78055060110290 - ColonPRO™ 4.0 | 2024-03-05 |
| 08055060110314 - GI Genius™ Module 100 | 2024-03-05 |
| 08055060110314 - GI Genius™ Module 100 | 2024-03-05 |
| 08055060110321 - GI Genius™ Module 200 | 2024-03-05 |
| 08055060110178 - USB K-switch | 2023-08-21 |
| 08055060110185 - Footswitch | 2023-08-21 |
Trademark Results [GI Genius]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GI GENIUS 88431147 not registered Live/Pending |
Covidien LP 2019-05-15 |
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