| Primary Device ID | 04035479166397 |
| NIH Device Record Key | d3b284b4-49ae-42b8-9168-ca5b23c8d0ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PSW |
| Version Model Number | 1904.U |
| Catalog Number | 448682 |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479166397 [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 | 2020-06-11 |
| Device Publish Date | 2020-06-03 |
| 04035479166397 | 1904.U |
| 04035479157692 | 1703.U |
| 04035479157678 | 1702.U |
| 04035479154165 | 1506.U/1 |
| 04035479152765 | 1507.U |
| 04035479150204 | 1502.U |
| 04035479149260 | 1501.U |
| 04035479147143 | 1403.U |
| 04035479140670 | 1304.U |
| 04035479140380 | 1307.U |
| 04035479151843 | 1506.U |
| 04035479150211 | 1503.U |
| 04035479174798 | 2100.U |
| 04035479160838 | 1801.U |
| 04035479157708 | 1704.U |
| 04035479162047 | 1802.U |
| 04035479164423 | 1901.U |
| 04035479164416 | 1804.U |
| 04035479178024 | 2201.U/1 |
| 04035479181543 | 2301.U |
| 04035479179632 | 2204.U |
| 04035479184292 | 2303.U |
| 04035479186012 | 2401.U |