FlexFlow Venous Cannula

GUDID 10803622147286

LIVANOVA USA, INC.

Cardiopulmonary bypass cannula, venous

• Primary Device ID: 10803622147286
• NIH Device Record Key: 59c00786-ac10-45e4-82db-28b125b705bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexFlow Venous Cannula
• Version Model Number: 200-200
• Company DUNS: 080914995
• Company Name: LIVANOVA USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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	00803622147289 [Primary]
GS1	10803622147286 [Package]; Contains: 00803622147289; Package: CASE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052081

FDA Product Code

• DWF: Catheter, cannula and tubing, vascular, cardiopulmonary bypass

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: 2020-10-06
• Device Publish Date: 2020-09-28

On-Brand Devices [FlexFlow Venous Cannula]

• 10803622128100: 200-200
• 10803622125819: 200-200
• 10803622147286: 200-200