| Primary Device ID | 00860005688111 |
| NIH Device Record Key | f7518071-741e-4586-a115-eea6871c66df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NuVision Connector Cable |
| Version Model Number | FG10594 |
| Company DUNS | 117379819 |
| Company Name | Nuvera Medical, 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 | 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 | 00860005688111 [Primary] |
| OBJ | Catheter, Ultrasound, Intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-15 |
| Device Publish Date | 2021-07-07 |
| 00860005688104 - NuVision ICE Catheter | 2021-07-15 The NUVISION™ ICE Catheter is a diagnostic ultrasound imaging catheter designed for intracardiac use. |
| 00860005688111 - NuVision Connector Cable | 2021-07-15The NuVision Connector Cable is a non-sterile, reusable connector cable intended to connect the sterile, single-use NuVision ICE Catheter to a qualified GE ultrasound cardiac imaging system. |
| 00860005688111 - NuVision Connector Cable | 2021-07-15 The NuVision Connector Cable is a non-sterile, reusable connector cable intended to connect the sterile, single-use NuVision IC |