N/A

GUDID 00896208000559

Livanova Canada Corp

Aortic heart valve bioprosthesis

• Primary Device ID: 00896208000559
• NIH Device Record Key: dc87da04-1432-4f72-9b1b-3f4f5673e161
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: N/A
• Company DUNS: 243661431
• Company Name: Livanova Canada Corp
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896208000559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P060038

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2016-08-08

Devices Manufactured by Livanova Canada Corp

• 00896208000078 - Mitroflow Aortic Handle: 2021-04-16
• 00896208000214 - Mitroflow Accessory Tray: 2021-04-16
• 08022057014924 - MITROFLOW VALSALVA CONDUIT: 2021-02-05
• 08022057014931 - MITROFLOW VALSALVA CONDUIT: 2021-02-05
• 08022057014948 - MITROFLOW VALSALVA CONDUIT: 2021-02-05
• 08022057014955 - MITROFLOW VALSALVA CONDUIT: 2021-02-05
• 00896208000092 - MITROFLOW: 2021-02-05
• 00896208000108 - MITROFLOW: 2021-02-05