Avalus™
GUDID 00643169976399
SIZERS 7400S AVALUS CEM GLOBAL
MEDTRONIC, INC.
Heart valve sizer, reusable| Primary Device ID | 00643169976399 |
| NIH Device Record Key | 67b3aa11-de69-4410-b463-4d57b25b9615 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Avalus™ |
| Version Model Number | 7400S |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169976399 [Primary] |
FDA Product Code
| DTI | SIZER, HEART-VALVE, PROSTHESIS |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169976399]
Moist Heat or Steam Sterilization
[00643169976399]
Moist Heat or Steam Sterilization
[00643169976399]
Moist Heat or Steam Sterilization
[00643169976399]
Moist Heat or Steam Sterilization
[00643169976399]
Moist Heat or Steam Sterilization
[00643169976399]
Moist Heat or Steam Sterilization
[00643169976399]
Moist Heat or Steam Sterilization
[00643169976399]
Moist Heat or Steam Sterilization
[00643169976399]
Moist Heat or Steam Sterilization
[00643169976399]
Moist Heat or Steam Sterilization
[00643169976399]
Moist Heat or Steam Sterilization
[00643169976399]
Moist Heat or Steam Sterilization
[00643169976399]
Moist Heat or Steam Sterilization
[00643169976399]
Moist Heat or Steam Sterilization
[00643169976399]
Moist Heat or Steam Sterilization
[00643169976399]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-10-14 |
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 |
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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