| Primary Device ID | 04035479005641 | 
| NIH Device Record Key | 2f0bedb9-c7f7-4f74-b297-8e24c1cb453a | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | IS1-C5PS | 
| Version Model Number | 118881 | 
| Catalog Number | 118881 | 
| 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 | true | 
| Lot Batch | false | 
| Serial Number | true | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains 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 | 
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04035479005641 [Primary] | 
| DTD | pacemaker lead Adaptor | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2021-02-05 | 
| Device Publish Date | 2014-08-25 | 
| 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 |