26MM X 3CM X 105CM NOVAFLEX+ DELIVERY SYSTEM 9355FS26A

GUDID 00690103193237

Edwards Lifesciences LLC

Aortic transcatheter heart valve bioprosthesis, stent-like framework

• Primary Device ID: 00690103193237
• NIH Device Record Key: 74e1c260-ad4d-4be2-b721-939bdd9aa5bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 26MM X 3CM X 105CM NOVAFLEX+ DELIVERY SYSTEM
• Version Model Number: 9355FS26
• Catalog Number: 9355FS26A
• 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
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00690103193237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130009

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-08-30

Devices Manufactured by Edwards Lifesciences LLC

• 57460691949275 - TRUWAVE, VAMP: 2026-02-12 PRESSURE MONITORING SET
• 50690103000417 - SWAN-GANZ: 2026-02-09 SWAN-GANZ THERMODILUTION CATHETER
• 00690103219753 - SAPIEN M3 Transcatheter Heart Valve: 2026-02-09 SAPIEN M3 Transcatheter Heart Valve
• 00690103219760 - SAPIEN M3 Dock Steerable Catheter: 2026-02-09 SAPIEN M3 Dock Steerable Catheter
• 00690103219777 - Edwards Commander M Delivery System: 2026-02-09 Edwards Commander M Delivery System
• 00690103219784 - Edwards 23F Guide Sheath: 2026-02-09 Edwards 23F Guide Sheath
• 00690103219791 - SAPIEN M3 Crimper: 2026-02-09 SAPIEN M3 Crimper
• 50690103000073 - CO-SET INJECTATE ICE BUCKET: 2025-07-24 CO-SET INJECTATE ICE BUCKET 6 PER CASE