CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIALBIOPROSTHESIS - MITRAL 6900PTFX33

GUDID 00690103163629

CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - MITRAL

Edwards Lifesciences LLC

Mitral heart valve bioprosthesis

• Primary Device ID: 00690103163629
• NIH Device Record Key: 3838f30b-eb4f-44bd-92b5-58742513f7ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIALBIOPROSTHESIS - MITRAL
• Version Model Number: 6900PTFX
• Catalog Number: 6900PTFX33
• 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	00690103163629 [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