CoreValve™

GUDID 00643169434301

COMPRESSION LOADING SYSTEM CLS-3000-18FR

MEDTRONIC COREVALVE LLC

Aortic transcatheter heart valve bioprosthesis, stent-like framework

• Primary Device ID: 00643169434301
• NIH Device Record Key: 557f3341-0ff6-4dcb-aaf3-92425071e8b4
• Commercial Distribution Discontinuation: 2016-01-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CoreValve™
• Version Model Number: CLS-3000-18FR
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00643169434301 [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: 4
• Public Version Date: 2018-10-26
• Device Publish Date: 2014-09-23

On-Brand Devices [CoreValve™]

• 00643169565630: DEL SYS DCS-C4-18F-23US COM 23 NP
• 00643169565623: DEL SYS DCS-C4-18F-US COM 26/29/31 NP
• 00643169448186: DELIV SYS DCS-C4-18F-US US COMM 26/29/31
• 00643169448179: DELIV SYS DCS-C4-18F-23US US COMM 23
• 00643169448162: COMP LOADING SYS CLS-3000-18F-US US COMM
• 00643169434301: COMPRESSION LOADING SYSTEM CLS-3000-18FR
• 00643169432376: DELIV SYS DCS-C4-18FR-23 ACCUTRAK 23
• 00643169432369: DELIV SYS DCS-C4-18FR ACCUTRAK 26/29/31