Ensemble™

GUDID 00643169588448

DELIV SYS NU1020 ENSEMBLE US

MEDTRONIC, INC.

Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis

• Primary Device ID: 00643169588448
• NIH Device Record Key: 5c403426-9973-408f-aa08-06009e59303b
• Commercial Distribution Discontinuation: 2016-05-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Ensemble™
• Version Model Number: NU1020
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• 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
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169588448 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140017

FDA Product Code

• NPV: Pulmonary 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: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2015-02-24

On-Brand Devices [Ensemble™]

• 00613994666000: TOOL NU1022 ENSEMBLE HDE
• 00613994665997: TOOL NU1020 ENSEMBLE HDE
• 00613994665980: TOOL NU1018 ENSEMBLE HDE
• 00643169588455: DELIV SYS NU1022 ENSEMBLE US
• 00643169588448: DELIV SYS NU1020 ENSEMBLE US
• 00643169588431: DELIV SYS NU1018 ENSEMBLE US
• 00643169415768: DELIV SYS NU1022 ENSEMBLE HDE
• 00643169415744: DELIV SYS NU1020 ENSEMBLE HDE
• 00643169415720: DELIV SYS NU1018 ENSEMBLE HDE