| Primary Device ID | 00864366000124 |
| NIH Device Record Key | f5ca1d4e-e4ec-462c-bfeb-172b0bd47675 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEVION S250i |
| Version Model Number | S250i |
| Catalog Number | MEVION S250i |
| Company DUNS | 199652145 |
| Company Name | MEVION MEDICAL SYSTEMS, 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00864366000124 [Primary] |
| LHN | System, Radiation Therapy, Charged-Particle, Medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-02-05 |
| 00864366000100 - Mevion Medical Systems | 2018-07-06 Proton Beam Radiation Therapy System |
| 00864366000124 - MEVION S250i | 2018-07-06 |
| 00864366000124 - MEVION S250i | 2018-07-06 |