| Primary Device ID | 00643169703278 |
| NIH Device Record Key | 2abda6df-9682-4abc-8bbe-9352e1888a6d |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 5433A |
| 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 | 00643169703278 [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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-08 |
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| 00199150026739 - NA | 2025-07-07 CUSTOM PACK BB12B00R3 3/8 SUPPORT |
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| 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 |