Avalus Ultra™
GUDID 00763000647063
AVALUSTM ULTRA 400U27 27MM VALVE SIZE
MEDTRONIC, INC.
Aortic heart valve bioprosthesis| Primary Device ID | 00763000647063 |
| NIH Device Record Key | f5bce3ea-e22a-4856-9af8-2e99abf771c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Avalus Ultra™ |
| Version Model Number | 400U27 |
| 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
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 |
| 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
| 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 |
| 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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000647063 [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
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