EVOQUE 9850EV52US

GUDID 00690103217469

EDWARDS EVOQUE VALVE, 52MM

Edwards Lifesciences LLC

Tricuspid transcatheter heart valve bioprosthesis

• Primary Device ID: 00690103217469
• NIH Device Record Key: e092272b-2df2-40f0-a2ba-6eb411e5f89e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOQUE
• Version Model Number: 9850EV52US
• Catalog Number: 9850EV52US
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103217469 [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: 2024-02-14
• Device Publish Date: 2024-02-06

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