| Primary Device ID | 20613994300083 |
| NIH Device Record Key | 4faa4f5e-866f-4cb3-953a-a162cb71eeaa |
| Commercial Distribution Discontinuation | 2016-01-04 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Version Model Number | 5441 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 3 |
| 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 | 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 |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994300089 [Unit of Use] |
| GS1 | 20613994300083 [Primary] |
| LWP | Implantable pulse generator, pacemaker (non-CRT) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-05-07 |
| Device Publish Date | 2014-09-23 |
| 00199150026654 - NA | 2025-07-07 CUSTOM PACK BB11E82R2 CB E SUPP |
| 00199150026661 - NA | 2025-07-07 CUSTOM PACK BB7D23R7 RADL |
| 00199150026722 - NA | 2025-07-07 CUSTOM PACK BB8T30R14 3/8 COMER |
| 00199150026739 - NA | 2025-07-07 CUSTOM PACK BB12B00R3 3/8 SUPPORT |
| 20199150026887 - NA | 2025-07-07 CUSTOM PACK BB8M18R1 2PK 1/4 LINES |
| 00199150026890 - NA | 2025-07-07 CUSTOM PACK BB6U14R7 TABLE PK |
| 00199150026906 - NA | 2025-07-07 CUSTOM PACK BB11S65R3 UAB L U N G T |
| 20199150026924 - NA | 2025-07-07 CUSTOM PACK BB11F17R2 5PK PERF DISTAL P |