EnVeo™ R

GUDID 00643169640337

DELIV SYS ENVEOR-N-US 34MM COMM

MEDTRONIC COREVALVE LLC

Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework
Primary Device ID00643169640337
NIH Device Record Key1f3a853f-77cf-4eb0-8c25-59b87cb30f6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnVeo™ R
Version Model NumberENVEOR-N-US
Company DUNS079527231
Company NameMEDTRONIC COREVALVE LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length107 Centimeter
Length107 Centimeter
Length107 Centimeter
Length107 Centimeter
Outer Diameter6.7 Millimeter
Length107 Centimeter
Outer Diameter6.7 Millimeter
Length107 Centimeter
Outer Diameter6.7 Millimeter
Length107 Centimeter
Outer Diameter6.7 Millimeter
Length107 Centimeter
Outer Diameter6.7 Millimeter
Length107 Centimeter
Outer Diameter6.7 Millimeter
Length107 Centimeter
Outer Diameter6.7 Millimeter
Length107 Centimeter
Outer Diameter6.7 Millimeter
Length107 Centimeter
Outer Diameter6.7 Millimeter
Length107 Centimeter
Outer Diameter6.7 Millimeter
Length107 Centimeter
Outer Diameter6.7 Millimeter
Length107 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store the catheter and LS in a cool, dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Store the catheter and LS in a cool, dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Store the catheter and LS in a cool, dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Store the catheter and LS in a cool, dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the catheter and LS in a cool, dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the catheter and LS in a cool, dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the catheter and LS in a cool, dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the catheter and LS in a cool, dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the catheter and LS in a cool, dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the catheter and LS in a cool, dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the catheter and LS in a cool, dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the catheter and LS in a cool, dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the catheter and LS in a cool, dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the catheter and LS in a cool, dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT expose any of the Medtronic CoreValve™ Evolut™ R system components to organic solvents, such as alcohol.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the catheter and LS in a cool, dry environment

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169640337 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPTAortic valve, prosthesis, percutaneously delivered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-05

On-Brand Devices [EnVeo™ R]

00643169640344LOADING SYS LS-ENVEOR-34-US COMM
00643169640337DELIV SYS ENVEOR-N-US 34MM COMM
00643169633377LOADING SYS LS-ENVEOR2629 US COMM
00643169633360LOADING SYS LS-ENVEOR23 US COMM
00643169633353DELIV SYS ENVEOR-US 23 26 29 US COMM

Trademark Results [EnVeo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENVEO
ENVEO
85813931 5041360 Live/Registered
Medtronic CV Luxembourg S.a.r.l.
2013-01-02

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