Primary Device ID | 00643169983182 |
NIH Device Record Key | 0df6f552-6874-474f-b232-b273bb13fbbb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Avalus™ |
Version Model Number | 40021 |
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 |
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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00643169983182 [Primary] |
LWR | heart-valve, non-allograft tissue |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-10-07 |
Device Publish Date | 2017-11-21 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() AVALUS 86625365 5745741 Live/Registered |
Medtronic, Inc. 2015-05-11 |