Avalus Ultra™
GUDID 00763000647056
AVALUSTM ULTRA 400U25 25MM VALVE SIZE
MEDTRONIC, INC.
Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis| Primary Device ID | 00763000647056 |
| NIH Device Record Key | 3d4d7903-7b83-4b7b-971a-c667be9d471d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Avalus Ultra™ |
| Version Model Number | 400U25 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 |
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 Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000647056 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P170006
FDA Product Code
| LWR | heart-valve, non-allograft tissue |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-13 |
| Device Publish Date | 2024-05-04 |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.