| Primary Device ID | 04035479156893 |
| NIH Device Record Key | d0ee1d12-dfaa-45f7-8099-ebd777ad06e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rivacor 5 DR-T |
| Version Model Number | 429563 |
| Catalog Number | 429563 |
| Company DUNS | 315620229 |
| Company Name | BIOTRONIK SE & Co. KG |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479156893 [Primary] |
| MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-10-28 |
| Device Publish Date | 2019-03-18 |
| 04035479188689 - SW HMSC 3.63 | 2025-05-15 |
| 04035479179687 - NEO | 2025-04-11 |
| 04035479179694 - PSW | 2025-04-11 |
| 04035479185817 - Neuro CP app 2300.U | 2025-04-04 |
| 04035479188733 - Neuro PR app 2400.U | 2025-04-04 |
| 04035479184445 - PatientApp 2.8 | 2025-02-20 |
| 04035479187927 - SW HMSC 3.62 | 2025-01-28 |
| 04035479188399 - NEO 2401.U/1 | 2024-12-26 |