1141M MITRIS RESILIA Mitral Valve Handle 1141M

GUDID 00690103219401

STAINLESS STEEL REUSABLE HANDLE FOR MITRIS

Edwards Lifesciences LLC

Heart valve prosthesis holder, reusable

• Primary Device ID: 00690103219401
• NIH Device Record Key: 2e579634-bb10-4b64-8b1d-082983bcb40b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1141M MITRIS RESILIA Mitral Valve Handle
• Version Model Number: 1141M
• Catalog Number: 1141M
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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)822-9637
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00690103219401 [Primary]

FDA Product Code

• DTJ: Holder, Heart-Valve, Prosthesis

Sterilization

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

[00690103219401]

Moist Heat or Steam Sterilization

[00690103219401]

Moist Heat or Steam Sterilization

[00690103219401]

Moist Heat or Steam Sterilization

[00690103219401]

Moist Heat or Steam Sterilization

[00690103219401]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-18
• Device Publish Date: 2024-07-10

Devices Manufactured by Edwards Lifesciences LLC

• 00690103219401 - 1141M MITRIS RESILIA Mitral Valve Handle: 2024-07-18STAINLESS STEEL REUSABLE HANDLE FOR MITRIS
• 00690103219401 - 1141M MITRIS RESILIA Mitral Valve Handle: 2024-07-18 STAINLESS STEEL REUSABLE HANDLE FOR MITRIS
• 00690103217124 - HemoSphere Vita: 2024-03-05 PRESSURE CONTROLLER KIT
• 00690103218848 - HemoSphere Vita: 2024-03-05 VitaWave Module
• 00690103218855 - HemoSphere Vita: 2024-03-05 HemoSphere Vita Monitor
• 00690103218862 - HemoSphere Vita: 2024-03-05 Vita Technology Module
• 50690103218898 - VitaWave: 2024-02-28 VitaWave Finger Cuff Adult
• 00690103217483 - EVOQUE: 2024-02-15 Edwards EVOQUE Stabilizer Plate
• 00690103217490 - EVOQUE: 2024-02-15 Edwards EVOQUE Loading System