| Primary Device ID | 00643169396968 |
| NIH Device Record Key | 410e3778-1d1c-4ff1-b9b4-4974ac3101f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 8555 |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169396968 [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 | 2015-03-03 |
| 00199150000012 - NA | 2025-03-07 CUSTOM PACK BB10J80R7 1/4CNTRI |
| 00763000997984 - NA | 2025-03-07 CUSTOM PACK BB11F56R9 PEDS V |
| 00763000999346 - NA | 2025-03-07 CUSTOM PACK BB3R67R6 SU AVLOOP |
| 20763000999364 - NA | 2025-03-07 CUSTOM PACK BB8A42R1 2PK TAVR PACK |
| 20763000999388 - NA | 2025-03-07 CUSTOM PACK BB3J83R2 5PK 38X332X16 |
| 20763000999401 - NA | 2025-03-07 CUSTOM PACK BB11J01R1 5PK BRIDGE SUP |
| 00763000999513 - NA | 2025-03-07 CUSTOM PACK BB11F41R3 ADLT SUPP PAC |
| 20763000999777 - NA | 2025-03-07 CUSTOM PACK BB12M84R1 10PK 3/8 SUPP LINE |