| Primary Device ID | 00817613020154 |
| NIH Device Record Key | 824e7473-73db-4d93-8780-1b957fa5cab8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EvolutionHD |
| Version Model Number | P-EVO.1 |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817613020154 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2018-02-23 |
| 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EVOLUTIONHD 85709162 4481955 Live/Registered |
Med X Change, Inc. 2012-08-21 |