| Primary Device ID | 00643169158108 |
| NIH Device Record Key | e0ef9f03-1155-402f-b3bb-4ac505c5eb94 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 8578 |
| Company DUNS | 796986144 |
| 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 | true |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| 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 | 00643169158108 [Primary] |
| LKK | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-04-27 |
| 00199150025381 - NA | 2025-06-27 CUSTOM PACK BB11P25R3 VCH CENT V A |
| 20199150025521 - NA | 2025-06-27 CUSTOM PACK BB9G37R2 5PK L VD AC |
| 00199150026326 - NA | 2025-06-27 CUSTOM PACK BB11Z33R8 ALINA CPB |
| 00199150026579 - NA | 2025-06-27 CUSTOM PACK BB5722R48 CHRT INF |
| 00199150026692 - NA | 2025-06-27 CUSTOM PACK BB8R73R14 NH ADULT PACK |
| 00199150026715 - NA | 2025-06-27 CUSTOM PACK BB6M71R12 CP PRIME |
| 00199150026746 - NA | 2025-06-27 CUSTOM PACK BB7A25R12 PED |
| 00199150026753 - NA | 2025-06-27 CUSTOM PACK BB12E34R4 SUPPORT PACK |