Ensemble™ ll

GUDID 00643169713901

DELIV SYS ENS1022 ENSEMBLE II US

MEDTRONIC, INC.

Pulmonary transcatheter heart valve bioprosthesis
Primary Device ID00643169713901
NIH Device Record Keyafe19204-09b9-4eb6-9b00-1184f7a89a28
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnsemble™ ll
Version Model NumberENS1022
Company DUNS006261481
Company NameMEDTRONIC, INC.
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169713901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPVPulmonary 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 Date2019-10-07
Device Publish Date2016-10-31

On-Brand Devices [Ensemble™ ll]

00643169713901DELIV SYS ENS1022 ENSEMBLE II US
00643169713895DELIV SYS ENS1020 ENSEMBLE II US
00643169713888DELIV SYS ENS1018 ENSEMBLE II US

Trademark Results [Ensemble]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENSEMBLE
ENSEMBLE
98717214 not registered Live/Pending
ENSEMBLE RCM, LLC
2024-08-26
ENSEMBLE
ENSEMBLE
98717210 not registered Live/Pending
ENSEMBLE RCM, LLC
2024-08-26
ENSEMBLE
ENSEMBLE
98510438 not registered Live/Pending
Molecula Corp.
2024-04-19
ENSEMBLE
ENSEMBLE
98112669 not registered Live/Pending
ENSEMBLE SERVICES, LLC
2023-08-01
ENSEMBLE
ENSEMBLE
98075175 not registered Live/Pending
Andersen Corporation
2023-07-07
ENSEMBLE
ENSEMBLE
97855502 not registered Live/Pending
Nufarm Americas Inc.
2023-03-24
ENSEMBLE
ENSEMBLE
97846173 not registered Live/Pending
Ensemble Investments, LLC
2023-03-19
ENSEMBLE
ENSEMBLE
97846167 not registered Live/Pending
ENSEMBLE SERVICES, LLC
2023-03-19
ENSEMBLE
ENSEMBLE
97304462 not registered Live/Pending
The Upper Deck Company
2022-03-09
ENSEMBLE
ENSEMBLE
97042063 not registered Live/Pending
Acuitive Solutions, LLC
2021-09-23
ENSEMBLE
ENSEMBLE
90886381 not registered Live/Pending
Happify, Inc.
2021-08-17
ENSEMBLE
ENSEMBLE
90811775 not registered Live/Pending
Element Biosciences, Inc.
2021-07-05

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