GI Genius™ Module 300
GUDID 08055060110338
GI Genius™ system with software ColonPRO™.
LINKVERSE SRL
Endoscopic video image interpretive unit| Primary Device ID | 08055060110338 |
| NIH Device Record Key | e5570838-a350-4a43-ab9c-304499f2da48 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GI Genius™ Module 300 |
| Version Model Number | GGM300-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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08055060110338 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K241887
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 | 2024-09-30 |
| Device Publish Date | 2024-09-22 |
Devices Manufactured by LINKVERSE SRL
| 78055060110344 - ColonPRO™ 4.0 | 2024-10-22 Software to be used in GI Genius™ systems. |
| 08055060110338 - GI Genius™ Module 300 | 2024-09-30GI Genius™ system with software ColonPRO™. |
| 08055060110338 - GI Genius™ Module 300 | 2024-09-30 GI Genius™ system with software ColonPRO™. |
| 78055060110290 - ColonPRO™ 4.0 | 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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