| Primary Device ID | 00817613020789 |
| NIH Device Record Key | 72454687-7811-4a17-bbae-02350f58058f |
| Commercial Distribution Discontinuation | 2019-06-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Viron R4K |
| Version Model Number | Evo4K240 |
| Company DUNS | 051244569 |
| Company Name | MED X CHANGE, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Manufacturing Date | true |
| 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 |
| Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |