EnVeo™ R
GUDID 00643169640337
DELIV SYS ENVEOR-N-US 34MM COMM
MEDTRONIC COREVALVE LLC
Aortic transcatheter heart valve bioprosthesis, stent-like framework| Primary Device ID | 00643169640337 |
| NIH Device Record Key | 1f3a853f-77cf-4eb0-8c25-59b87cb30f6a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EnVeo™ R |
| Version Model Number | ENVEOR-N-US |
| Company DUNS | 079527231 |
| Company Name | MEDTRONIC COREVALVE LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | 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 |
Device Dimensions
| Length | 107 Centimeter |
| Length | 107 Centimeter |
| Length | 107 Centimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6.7 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6.7 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6.7 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6.7 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6.7 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6.7 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6.7 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6.7 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6.7 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6.7 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6.7 Millimeter |
| Length | 107 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169640337 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P130021
FDA Product Code
| NPT | Aortic valve, prosthesis, percutaneously delivered |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-05 |
On-Brand Devices [EnVeo™ R]
| 00643169640344 | LOADING SYS LS-ENVEOR-34-US COMM |
| 00643169640337 | DELIV SYS ENVEOR-N-US 34MM COMM |
| 00643169633377 | LOADING SYS LS-ENVEOR2629 US COMM |
| 00643169633360 | LOADING SYS LS-ENVEOR23 US COMM |
| 00643169633353 | DELIV SYS ENVEOR-US 23 26 29 US COMM |
Trademark Results [EnVeo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENVEO 85813931 5041360 Live/Registered |
Medtronic CV Luxembourg S.a.r.l. 2013-01-02 |
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