| 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 |
| 00199150021055 - NA | 2025-06-06 CUSTOM PACK BB11B15R1 CHP CIRCUIT |
| 00199150021062 - NA | 2025-06-06 CUSTOM PACK BB11F90R3 ADULT ECC3/8 |
| 00199150021079 - NA | 2025-06-06 CUSTOM PACK BB7C59R10 E C L S |
| 20199150021110 - NA | 2025-06-06 CUSTOM PACK BB6X07R3 2PK 38 E |
| 20199150021134 - NA | 2025-06-06 CUSTOM PACK BB12A97R1 5PK PIGTAIL |
| 00199150021147 - NA | 2025-06-06 CUSTOM PACK BB10Z01R17 SUPPORT PACK |
| 20199150021165 - NA | 2025-06-06 CUSTOM PACK BB10Y40R1 5PK BRIDGE PACK |
| 20199150021653 - NA | 2025-06-06 CUSTOM PACK BB12D52R2 10PK 3/16 BRIDGE |