CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT 430014MM

GUDID 00690103021790

Edwards Lifesciences LLC

Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft Aortic heart valve bioprosthesis/synthetic polymer aorta graft

• Primary Device ID: 00690103021790
• NIH Device Record Key: 86d4fa69-1a23-49a7-b598-3d4917820c64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT
• Version Model Number: 4300
• Catalog Number: 430014MM
• 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: false
• Serial Number: true
• 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)822-9637
• 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
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103021790 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P870056

FDA Product Code

• DYE: replacement Heart-valve

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: 2015-09-09

On-Brand Devices [CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT]

• 00690103021851: 4300
• 00690103021844: 4300
• 00690103021837: 4300
• 00690103021820: 4300
• 00690103021813: 4300
• 00690103021806: 4300
• 00690103021790: 4300
• 00690103021783: 4300