| Primary Device ID | 20613994300083 |
| NIH Device Record Key | 4faa4f5e-866f-4cb3-953a-a162cb71eeaa |
| Commercial Distribution Discontinuation | 2016-01-04 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Version Model Number | 5441 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 3 |
| 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 |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994300089 [Unit of Use] |
| GS1 | 20613994300083 [Primary] |
| LWP | Implantable pulse generator, pacemaker (non-CRT) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-05-07 |
| Device Publish Date | 2014-09-23 |
| 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 |