| Primary Device ID | 04035479166403 |
| NIH Device Record Key | 5b11e17e-abe9-4f2a-afb4-69f33b2d03db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Home Monitoring Service Center |
| Version Model Number | 3.45 |
| Catalog Number | 448494 |
| 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 | true |
| Serial Number | false |
| 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479166403 [Primary] |
| OSR | Pacemaker/icd/crt non-implanted components |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-19 |
| Device Publish Date | 2019-09-11 |
| 04035479161750 | 3.43 |
| 04035479166106 | 3.44 |
| 04035479166403 | 3.45 |
| 04035479167493 | 3.46 |
| 04035479167509 | 3.47 |
| 04035479168773 | 3.48 |
| 04035479169466 | 3.49 |
| 04035479161743 | 3.42 |
| 04035479158248 | 3.38 |
| 04035479152413 | 3.35 |
| 04035479148867 | 3.33 |
| 04035479148843 | 3.31 |
| 04035479144258 | 3.29 |
| 07640130457300 | 3.50 |
| 04035479175559 | 3.51 |
| 04035479176587 | 3.53 |
| 04035479177942 | 3.54 |
| 04035479179779 | 3.55 |
| 04035479182045 | 3.57 |
| 04035479183264 | 3.58 |