| Primary Device ID | 00844735006025 |
| NIH Device Record Key | 8b2e38bd-c722-4eef-b1ab-be0b0e878461 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GEM FLOW COUPLER |
| Version Model Number | GEM2755 FC |
| Catalog Number | 515101350010 |
| Company DUNS | 031284586 |
| Company Name | SYNOVIS MICRO COMPANIES ALLIANCE, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844735006025 [Primary] |
| DPW | FLOWMETER, BLOOD, CARDIOVASCULAR |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-10-08 |
| 00844735006032 | The FlowCOUPLER System consists of a FlowCOUPLER Device and a FlowCOUPLER Monitor. The FlowCOUPL |
| 00844735006025 | The FlowCOUPLER System consists of a FlowCOUPLER Device and a FlowCOUPLER Monitor. The FlowCOUPL |
| 00844735006018 | The FlowCOUPLER System consists of a FlowCOUPLER Device and a FlowCOUPLER Monitor. The FlowCOUPL |
| 00844735006001 | The FlowCOUPLER System consists of a FlowCOUPLER Device and a FlowCOUPLER Monitor. The FlowCOUPL |
| 00844735005998 | The FlowCOUPLER System consists of a FlowCOUPLER Device and a FlowCOUPLER Monitor. The FlowCOUPL |