PERCEVAL PLUS

GUDID 00896208000825

Livanova Canada Corp

Aortic heart valve bioprosthesis

• Primary Device ID: 00896208000825
• NIH Device Record Key: a0bd4fb6-2a9e-4dfd-b102-41af3e30799a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERCEVAL PLUS
• Version Model Number: PVF-XL
• 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	00896208000825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150011

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: 2021-02-03
• Device Publish Date: 2021-01-26

On-Brand Devices [PERCEVAL PLUS]

• 00896208000825: PVF-XL
• 00896208000818: PVF-L
• 00896208000801: PVF-M
• 00896208000795: PVF-S