Avalus Ultra™
GUDID 00763000647094
AVALUSTM ULTRA 7400SU SIZERS
MEDTRONIC, INC.
Aortic heart valve bioprosthesis| Primary Device ID | 00763000647094 |
| NIH Device Record Key | cc847ce4-b11e-4a04-9c7d-9342d19a8c3f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Avalus Ultra™ |
| Version Model Number | 7400SU |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | 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 |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000647094 [Primary] |
FDA Product Code
| DTI | SIZER, HEART-VALVE, PROSTHESIS |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
[00763000647094]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-13 |
| Device Publish Date | 2024-05-05 |
On-Brand Devices [Avalus Ultra™]
| 00763000647094 | AVALUSTM ULTRA 7400SU SIZERS |
| 00763000647070 | AVALUSTM ULTRA 400U29 29MM VALVE SIZE |
| 00763000647063 | AVALUSTM ULTRA 400U27 27MM VALVE SIZE |
| 00763000647056 | AVALUSTM ULTRA 400U25 25MM VALVE SIZE |
| 00763000647049 | AVALUSTM ULTRA 400U23 23MM VALVE SIZE |
| 00763000647032 | AVALUSTM ULTRA 400U21 21MM VALVE SIZE |
| 00763000647025 | AVALUSTM ULTRA 400U19 19MM VALVE SIZE |
Trademark Results [Avalus Ultra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AVALUS ULTRA 97747710 not registered Live/Pending |
Medtronic, Inc 2023-01-10 |
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