| Primary Device ID | 00613994338754 |
| NIH Device Record Key | 5e4de6f3-faec-4fd9-8681-3b30856cf9b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 8835 |
| 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 | false |
| 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994338754 [Primary] |
| LKK | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-23 |
| 20199150019568 - NA | 2025-05-26 CUSTOM PACK BB11V60R1 20PK VUMC PIGTAILS |
| 20199150019582 - NA | 2025-05-26 CUSTOM PACK BB4P07R2 2PK PLEG LIN |
| 20199150020717 - NA | 2025-05-26 CUSTOM PACK BB3G62R1 5PK SUPP SUCKR |
| 00763000841607 - Cardioblate™ Gemini™-s | 2025-05-26 CLAMP 49351 CARDIOBLATE GEMINI-S FT |
| 00199150018154 - NA | 2025-05-23 CUSTOM PACK BB10N41R2 SUPPORT SM |
| 00199150019618 - NA | 2025-05-23 CUSTOM PACK BB12Q14R ADULT OXY/TIES |
| 00199150019625 - NA | 2025-05-23 CUSTOM PACK BB9N98R17 PUMP PACK |
| 00199150019632 - NA | 2025-05-23 CUSTOM PACK BB11P48R5 ATTRNSFN SET |