| Primary Device ID | 00859144004234 |
| NIH Device Record Key | d43b983f-bcb4-413b-aa77-3714643687fd |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 5500 |
| Catalog Number | 100033-301 |
| Company DUNS | 052373680 |
| Company Name | CVRX, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 00859144004234 [Primary] |
| DSR | Stimulator, Carotid Sinus Nerve |
| 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 | 2015-01-21 |
| 00859144004432 - BAROSTIM NEO | 2019-08-30 BAROSTIM NEO Model 2102 Implantable Pulse Generator (US Commercial) |
| 00859144004449 - BAROSTIM Programmer | 2019-08-30 Model 9010 Programmer System (US Commercial) |
| 00859144004456 - BAROSTIM Lead Repair Kit | 2019-08-30 Model 5010 Carotid Sinus Lead Repair Kit (US Commercial) |
| 00859144004463 - BAROSTIM NEO | 2019-08-30 BAROSTIM NEO Model 1036 Carotid Sinus Lead Kit (US Commercial) |
| 00859144004470 - BAROSTIM NEO | 2019-08-30 BAROSTIM NEO Model 1037 Carotid Sinus Lead Kit |
| 00859144004128 - NA | 2018-03-29 Programmer System |
| 00859144004203 - NA | 2018-03-29 Carotid Sinus Lead Repair Kit |
| 00859144004210 - Neo Legacy | 2018-03-29 Neo Legacy Implantable Pulse Generator |