EnVeo™ R

GUDID 00643169800915

DELIV SYS EnVeoR-US OREVAC 18Fr

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 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 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 ID00643169800915
NIH Device Record Key1d522ecc-5048-44a9-b105-5192de708c50
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnVeo™ R
Version Model NumberENVEOR-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
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
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

Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter
Length107 Centimeter
Outer Diameter6 Millimeter

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 *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 *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 *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 *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 *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 *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 *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 *Store the catheter and LS in a cool, dry environment

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169800915 [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 Date2017-08-07

On-Brand Devices [EnVeo™ R]

00643169956193DELIV SYS ENVEOR-N-US 34MM COMM
00643169934122LOADING SYSTEM LS-MDT2-2629-US
00643169934115LOADING SYSTEM LS-MDT2-23-US
00643169800939DELIV SYS EnVeoR-N-US OREVAC 20Fr
00643169800915DELIV SYS EnVeoR-US OREVAC 18Fr
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