| Primary Device ID | 00842000100591 |
| NIH Device Record Key | 24739af9-fc9a-42c0-afe1-0b2068cc942f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Merge Cardio |
| Version Model Number | 10.1 |
| Company DUNS | 065626069 |
| Company Name | MERGE HEALTHCARE SOLUTIONS 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 | 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 | 00842000100591 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-05-23 |
| Device Publish Date | 2017-02-10 |
| 00842000100591 | Standalone software application |
| 00842000100416 | Standalone software application |
| 00842000100041 | Standalone software application. |
| 00842000100768 | 12.0.1 |
| 00842000100928 | Standalone software application |
| 00842000101123 | Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascu |