CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIALBIOPROSTHESIS - MITRAL 6900PTFX31

GUDID 00690103163612

CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - MITRAL

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: 00690103163612
• NIH Device Record Key: 881ce30f-9196-4873-8dd1-4993ac0a6043
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIALBIOPROSTHESIS - MITRAL
• Version Model Number: 6900PTFX
• Catalog Number: 6900PTFX31
• 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
• 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: true
• OTC Over-The-Counter: 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	00690103163612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P860057

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: 7
• Public Version Date: 2019-03-28
• Device Publish Date: 2014-08-30

On-Brand Devices [CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIALBIOPROSTHESIS - MITRAL]

• 00690103163629: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - MITRAL
• 00690103163612: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - MITRAL
• 00690103163605: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - MITRAL
• 00690103163599: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - MITRAL
• 00690103163582: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - MITRAL