CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS - MITRAL 6625ESRLP27

GUDID 00690103021882

Edwards Lifesciences LLC

Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis Mitral heart valve bioprosthesis

• Primary Device ID: 00690103021882
• NIH Device Record Key: a7846578-ec9d-4ae4-9db6-4ddc67936e4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS - MITRAL
• Version Model Number: 6625-ESR-LP
• Catalog Number: 6625ESRLP27
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

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

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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103021882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P870077

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: 2014-08-30

On-Brand Devices [CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS - MITRAL]

• 00690103022032: CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS - MITRAL
• 00690103022025: CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS - MITRAL
• 00690103022018: CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS - MITRAL
• 00690103022001: CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS - MITRAL
• 00690103021998: CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS - MITRAL
• 00690103021929: 6625-ESR-LP
• 00690103021912: 6625-ESR-LP
• 00690103021905: 6625-ESR-LP
• 00690103021899: 6625-ESR-LP
• 00690103021882: 6625-ESR-LP