EDWARDS CERTITUDE DELIVERY SYSTEM 9600SDS20A

GUDID 00690103194135

EDWARDS CERTITUDE DELIVERY SYSTEM

Edwards Lifesciences LLC

Aortic transcatheter heart valve bioprosthesis, stent-like framework

• Primary Device ID: 00690103194135
• NIH Device Record Key: fcae6b25-f55e-459c-ba6f-4e81c613e440
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDWARDS CERTITUDE DELIVERY SYSTEM
• Version Model Number: 9600SDS20
• Catalog Number: 9600SDS20A
• 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: 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *COOL, DRY PLACE.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103194135 [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: 2018-07-06
• Device Publish Date: 2017-01-09

On-Brand Devices [EDWARDS CERTITUDE DELIVERY SYSTEM]

• 00690103201451: Edwards Certitude Delivery System
• 00690103201444: Edwards Certitude Delivery System
• 00690103201192: Edwards Certitude Delivery System
• 00690103201185: Edwards Certitude Delivery System
• 00690103194166: EDWARDS CERTITUDE DELIVERY SYSTEM
• 00690103194159: EDWARDS CERTITUDE DELIVERY SYSTEM
• 00690103194142: EDWARDS CERTITUDE DELIVERY SYSTEM
• 00690103194135: EDWARDS CERTITUDE DELIVERY SYSTEM