| Primary Device ID | 30841716102845 |
| NIH Device Record Key | 3ec9c762-95f3-4121-8d6d-992db779e722 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RXi® Console Cable |
| Version Model Number | 018726 |
| Company DUNS | 926684994 |
| Company Name | ACIST MEDICAL SYSTEMS, 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 30841716102845 [Primary] |
| OBI | Catheter, Pressure Monitoring, Cardiac |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-25 |
| Device Publish Date | 2021-06-17 |
| 30841716103514 - ACIST HDi® System Console | 2024-11-21 HDi System Console |
| 30841716103521 - ACIST HDi® Power Supply | 2024-11-21 HDi Power Supply |
| 40841716103511 - ACIST HDi® HD IVUS System | 2024-11-21 HDi System Overpack Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply |
| 20841716100004 - ACIST Navvus® Catheter | 2024-06-12 Navvus Catheter, p/n 701481-002 |
| 10841716100014 - ACIST Navvus® Catheter | 2024-06-12 Navvus Catheter, p/n 701481-003 |
| 30841716100384 - ACIST RXi® System | 2024-06-12 RXi System Console, p/n 701309-008 |
| 30841716101732 - ACIST RXi® System | 2024-06-12 RXi System Console, p/n 701640-001 |
| 10841716102421 - AngioTouch® Kit | 2024-06-07 Model AT X65 |