| Primary Device ID | 00643169101081 |
| NIH Device Record Key | c22da178-835c-40f0-873f-31a8dc79039a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 8598A |
| 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 | 00643169101081 [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 |
| 00199150000296 - NA | 2025-03-14 CUSTOM PACK BB10R33R2 WHLG SUPT |
| 00199150000302 - NA | 2025-03-14 CUSTOM PACK BB12D68R1 1/4 DAV PK |
| 20199150000320 - NA | 2025-03-14 CUSTOM PACK BB10V15R5 5PK SUPP |
| 20199150000344 - NA | 2025-03-14 CUSTOM PACK BB8S27R1 5PK Y LINE CB |
| 20199150000368 - NA | 2025-03-14 CUSTOM PACK BB11P52R1 5PK Y LINE CB |
| 00199150000616 - NA | 2025-03-14 CUSTOM PACK BB11N74R15 CCS-ST MARKS |
| 00199150000623 - NA | 2025-03-14 CUSTOM PACK BB7E57R18 PUMP |
| 00199150000630 - NA | 2025-03-14 CUSTOM PACK BB11B96R4 HEART PACK |