Avalus™
GUDID 00643169983175
VALVE 40019 AVALUS AOR MMX U30 US
MEDTRONIC, INC.
Aortic heart valve bioprosthesis| Primary Device ID | 00643169983175 |
| NIH Device Record Key | 359fcd5f-91fe-42a4-91c0-c1c683a9b027 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Avalus™ |
| Version Model Number | 40019 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169983175 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2017-11-21 |
On-Brand Devices [Avalus™]
| 00643169983212 | VALVE 40027 AVALUS AOR MMX U30 US |
| 00643169983205 | VALVE 40025 AVALUS AOR MMX U30 US |
| 00643169983199 | VALVE 40023 AVALUS AOR MMX U30 US |
| 00643169983182 | VALVE 40021 AVALUS AOR MMX U30 US |
| 00643169983175 | VALVE 40019 AVALUS AOR MMX U30 US |
| 00643169976405 | HANDLE 7420 VLV HNDLE 234MM CEM GLOBAL |
| 00643169976399 | SIZERS 7400S AVALUS CEM GLOBAL |
| 00643169983229 | VALVE 40029 AVALUS AOR MMX U30 US |
| 00643169739246 | HANDLE 7420 VLV HNDLE 234MM 29L |
Trademark Results [Avalus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AVALUS 86625365 5745741 Live/Registered |
Medtronic, Inc. 2015-05-11 |
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