| Primary Device ID | 04035479143176 |
| NIH Device Record Key | 51a7cce3-94b1-4fae-81f1-1133b842f8d4 |
| Commercial Distribution Discontinuation | 2020-10-16 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Model 3145 |
| Version Model Number | 369041 |
| Catalog Number | 369041 |
| Company DUNS | 315620229 |
| Company Name | BIOTRONIK SE & Co. KG |
| 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 | 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |