EVOQUE 9850TDSUS

GUDID 00690103217520

Edwards EVOQUE Tricuspid Delivery System

Edwards Lifesciences LLC

Tricuspid transcatheter heart valve bioprosthesis

• Primary Device ID: 00690103217520
• NIH Device Record Key: fcf2ab53-83bf-4466-a4e7-ac240197018e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOQUE
• Version Model Number: 9850TDSUS
• Catalog Number: 9850TDSUS
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences 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: true
• Expiration Date: true
• 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)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103217520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P230013

FDA Product Code

• NPW: Prosthesis, Tricuspid Valve, Percutaneously Delivered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-15
• Device Publish Date: 2024-02-07

On-Brand Devices [EVOQUE]

• 00690103217476: Edwards EVOQUE Stabilizer Base
• 00690103217469: EDWARDS EVOQUE VALVE, 52MM
• 00690103217452: EDWARDS EVOQUE VALVE, 48MM
• 00690103217445: EDWARDS EVOQUE VALVE, 44MM
• 00690103217520: Edwards EVOQUE Tricuspid Delivery System
• 00690103217513: Edwards EVOQUE Stabilizer
• 00690103217506: Edwards EVOQUE Dilator Kit (24, 28, 33 Fr dilators)
• 00690103217490: Edwards EVOQUE Loading System
• 00690103217483: Edwards EVOQUE Stabilizer Plate