| Primary Device ID | 00613994533579 |
| NIH Device Record Key | 79d5e761-c24e-48ec-bea8-1a7eae6189bb |
| Commercial Distribution Discontinuation | 2017-03-06 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Version Model Number | 8516 |
| 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 | 00613994533579 [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 | 2014-09-23 |
| 00763000944322 - NA | 2024-04-23 CUSTOM PACK HY4953R31 MEMB PK |
| 00763000944339 - NA | 2024-04-23 CUSTOM PACK BB12F73R1 AHO PACK |
| 00763000944346 - NA | 2024-04-23 CUSTOM PACK BB12F35R5 A PACK |
| 00763000945558 - NA | 2024-04-23 CUSTOM PACK CB11X44R5 3/16X1/4 NEO |
| 00763000943844 - NA | 2024-04-12 CUSTOM PACK BB11J59R5 PEDS |
| 00763000943851 - NA | 2024-04-12 CUSTOM PACK BB12F35R3 A PACK |
| 00763000943868 - NA | 2024-04-12 CUSTOM PACK CB9J12R4 PED SPRT |
| 00763000943899 - NA | 2024-04-12 CUSTOM PACK BB12E09R3 INVO DCD |