| Primary Device ID | 00842000100515 |
| NIH Device Record Key | cbf03b89-9b14-4564-a16a-4881899bc683 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Merge Hemo Link Assembly |
| Version Model Number | 77-00327-00 |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842000100515 [Primary] |
| DQK | Computer, Diagnostic, Programmable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-05 |
| Device Publish Date | 2019-06-27 |
| 00842000101215 - Merge PACS | 2025-09-11 |
| 00842000101208 - Merge PACS | 2025-08-28 |
| 00842000101222 - Merge Universal Viewer | 2025-08-11 |
| 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 |