EvolutionHD
GUDID 00817613020161
EvolutionHD System, Rev 1
MED X CHANGE, INC.
Endoscopic video image processing unit| Primary Device ID | 00817613020161 |
| NIH Device Record Key | f6b573e1-bfd1-4726-984e-228da44152af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EvolutionHD |
| Version Model Number | Evo.1O |
| Company DUNS | 051244569 |
| Company Name | MED X CHANGE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 105 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 105 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 105 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 105 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 105 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 105 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 105 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 105 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 105 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 105 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 105 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 105 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 105 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817613020161 [Primary] |
FDA Product Code
| LMB | Device, Digital Image Storage, Radiological |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2018-03-30 |
On-Brand Devices [EvolutionHD]
| 00817613020352 | Mitaka EvolutionHD System, Rev 1 |
| 00817613020338 | Leica EvolutionHD System, Rev 1 |
| 00817613020239 | Leica EvolutionHD System, Rev 1 |
| 00817613020161 | EvolutionHD System, Rev 1 |
| 00817613020154 | Accessory Pack for the EvolutionHD, Rev 1 |
| 00817613020055 | Mitaka EvolutionHD System, Rev 1 |
| 00817613020048 | Inspire EvolutionHD System, Rev 1 |
| 00817613020031 | EvolutionHD System, Rev 1 |
Trademark Results [EvolutionHD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EVOLUTIONHD 85709162 4481955 Live/Registered |
Med X Change, Inc. 2012-08-21 |
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