FREEDOM SOLO

GUDID 00896208000399

Livanova Canada Corp

Aortic heart valve bioprosthesis

• Primary Device ID: 00896208000399
• NIH Device Record Key: c4fe5343-4810-43e6-be1d-e4fd3f15ef70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREEDOM SOLO
• Version Model Number: ARTSG
• Company DUNS: 243661431
• Company Name: Livanova Canada Corp
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	00896208000399 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130011

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: 2014-09-19

On-Brand Devices [FREEDOM SOLO]

• 00896208000405: ARTSG
• 00896208000399: ARTSG
• 00896208000382: ARTSG
• 00896208000375: ARTSG