CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING - MITRAL 4400M38

GUDID 00690103020113

Edwards Lifesciences LLC

Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring Mitral annuloplasty ring

• Primary Device ID: 00690103020113
• NIH Device Record Key: c628df72-f25f-427e-b642-7cb8b81c8c21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING - MITRAL
• Version Model Number: 4400
• Catalog Number: 4400M38
• 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: true
• Manufacturing Date: true
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00690103020113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912554

FDA Product Code

• KRH: RING, ANNULOPLASTY

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: 2015-09-24

On-Brand Devices [CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING - MITRAL]

• 00690103020120: 4400
• 00690103020113: 4400
• 00690103020106: 4400
• 00690103020090: 4400
• 00690103020083: 4400
• 00690103020076: 4400
• 00690103020069: 4400
• 00690103020052: 4400