SAPIEN 3 Ultra Delivery System 9630TF23A

GUDID 00690103201246

U.S. Edwards SAPIEN 3 Ultra Delivery System (26mm)

Edwards Lifesciences LLC

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00690103201246
• NIH Device Record Key: 6e952784-3615-4dea-b8ea-a0eb6ec924e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAPIEN 3 Ultra Delivery System
• Version Model Number: 9630TF23
• Catalog Number: 9630TF23A
• 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: 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: 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
• 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
• 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
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system must be stored in a cool, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103201246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140031

FDA Product Code

• NPU: Prosthesis, Mitral Valve, 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: 2019-06-19
• Device Publish Date: 2019-01-08

On-Brand Devices [SAPIEN 3 Ultra Delivery System]

• 00690103201260: U.S. Edwards SAPIEN 3 Ultra Delivery System (29mm)
• 00690103201253: 26mm SAPIEN 3 Ultra Delivery System
• 00690103201246: U.S. Edwards SAPIEN 3 Ultra Delivery System (26mm)
• 00690103201239: Edwards SAPIEN 3 Ultra Delivery System (20mm) US