| Primary Device ID | 04035479149260 | 
| NIH Device Record Key | 6a32b1db-9584-4db7-82a7-4a551211c4c6 | 
| Commercial Distribution Discontinuation | 2020-10-16 | 
| Commercial Distribution Status | Not in Commercial Distribution | 
| Brand Name | PSW | 
| Version Model Number | 1501.U | 
| Catalog Number | 408849 | 
| 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 | 
| Phone | +1(888)345-0374 | 
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 | 
| jon.brumbaugh@biotronik.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04035479149260 [Primary] | 
| OSR | Pacemaker/icd/crt non-implanted components | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2020-10-19 | 
| Device Publish Date | 2015-04-15 | 
| 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 | 
| 04035479179694 | 2202.U |