SOLO SMART

GUDID 00896208000474

Livanova Canada Corp

Aortic heart valve bioprosthesis

• Primary Device ID: 00896208000474
• NIH Device Record Key: a5ec3656-af03-4c1c-bb80-87844ae4230b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLO SMART
• Version Model Number: ARTSMT
• 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	00896208000474 [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 [SOLO SMART]

• 00896208000498: ARTSMT
• 00896208000481: ARTSMT
• 00896208000474: ARTSMT
• 00896208000467: ARTSMT