MITRIS RESILIA Mitral Valve 11400M33

GUDID 00690103205572

RESILIA Mitral Valve, size 33 mm

Edwards Lifesciences LLC

Mitral heart valve bioprosthesis

• Primary Device ID: 00690103205572
• NIH Device Record Key: 17781a11-0ba2-4770-a474-1f11063bb7ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MITRIS RESILIA Mitral Valve
• Version Model Number: 11400M
• Catalog Number: 11400M33
• 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
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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: 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
• 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
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103205572 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150048

FDA Product Code

• LWR: Heart-Valve, Non-Allograft Tissue

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-31
• Device Publish Date: 2022-03-23

On-Brand Devices [MITRIS RESILIA Mitral Valve]

• 00690103205572: RESILIA Mitral Valve, size 33 mm
• 00690103205565: RESILIA Mitral Valve, size 31 mm
• 00690103205558: RESILIA Mitral Valve, size 29 mm
• 00690103205541: RESILIA Mitral Valve, size 27 mm
• 00690103205534: RESILIA Mitral Valve, size 25 mm