| Primary Device ID | 00681490132558 |
| NIH Device Record Key | ad15df77-f23d-45b8-ba8c-1042dd9b2502 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 5437 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| 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(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00681490132558 [Primary] |
| DXY | implantable pacemaker Pulse-generator |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-23 |
| 00199150057177 - NA | 2025-11-24 CUSTOM PACK BB3Z71R34 HLO PRIMARY |
| 00199150058976 - NA | 2025-11-24 CUSTOM PACK PDBB12P71R2 HLO HEATT |
| 00199150060122 - NA | 2025-11-24 CUSTOM PACK BB12S52R1 EVL 3/8 PACK |
| 00763000849801 - Liberant™ | 2025-11-24 CONSOLE LMT-BCU LIBERANT |
| 00763000913069 - InterStim™ SureScan™ | 2025-11-24 LEAD 978A128 ISTM 2.16MM EUMDR EMAN LI08 |
| 00763000913083 - InterStim™ SureScan™ | 2025-11-24 LEAD 978A133 ISTM 2.16MM EMAN EUMDR LI08 |
| 00763000913106 - InterStim™ SureScan™ | 2025-11-24 LEAD 978A141 ISTM 2.16MM EMAN EUMDR LI08 |
| 00763000913120 - InterStim™ SureScan™ | 2025-11-24 LEAD 978B128 ISTM 4.32MM EUMDR EMAN LI08 |