| Primary Device ID | 00842000100140 |
| NIH Device Record Key | 29dfacc9-9675-439a-b4ba-5f7607922360 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Merge Eye Station |
| Version Model Number | 11.6.1 |
| Company DUNS | 065626069 |
| Company Name | MERGE HEALTHCARE SOLUTIONS INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842000100140 [Primary] |
| NFJ | System, Image Management, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-06-21 |
| Device Publish Date | 2016-12-01 |
| 00842000101178 - CADstream | 2024-11-22 Standalone software application |
| 00842000101079 - Merge Hemo | 2024-09-18 |
| 00842000101154 - Merge PACS | 2024-07-09 |
| 00842000101161 - Merge Universal Viewer | 2024-05-08 |
| 00842000101123 - Merge Cardio | 2024-02-13 Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management syste |
| 00842000101147 - Merge PACS | 2023-12-06 |
| 00842000101086 - Merge PACS | 2023-09-22 |
| 00842000101130 - Merge Universal Viewer | 2023-09-07 |