| 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 |
| 00763000582890 - Avalus™ 7400S | 2025-03-03 SIZERS 7400S AVALUS CEM GLOBAL |
| 00763000582906 - Valve Handle 7420 | 2025-03-03 HANDLE 7420 VLV HNDLE 234MM CEM GLOBAL |
| 00763000911089 - NA | 2025-03-03 FOOT SWITCH NITRONFS GLOBAL |
| 20763000954363 - N/A | 2025-03-03 PATCH AFR-00007 LOCATION REF 4PK US |
| 20763000999197 - NA | 2025-03-03 CUSTOM PACK BB2N27R2 5PK CARDIO LN |
| 20763000999753 - NA | 2025-03-03 CUSTOM PACK 12M79R 10PK TTS |
| 20763000999210 - NA | 2025-02-28 CUSTOM PACK BB12D77R2 5PK HEAD PACK |
| 20763000999234 - NA | 2025-02-28 CUSTOM PACK BB12D89R1 5PK HEAD ACC PACK |