EasyFlow Duo Cannula

GUDID 10803622124188

LIVANOVA USA, INC.

Cardiopulmonary bypass cannula, arterial

• Primary Device ID: 10803622124188
• NIH Device Record Key: 9f9aa82f-7960-477e-9536-490771d3679f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyFlow Duo Cannula
• Version Model Number: Duo Cannula
• 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	00803622124181 [Primary]
GS1	10803622124188 [Package]; Contains: 00803622124181; Package: CASE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091542

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-15
• Device Publish Date: 2015-03-10

On-Brand Devices [EasyFlow Duo Cannula]

• 10803622136365: Duo Cannula
• 10803622128070: Duo Cannula
• 10803622124195: Duo Cannula
• 10803622124188: Duo Cannula
• 10803622147309: Duo Cannula
• 10803622147279: Duo Cannula
• 10803622147996: Duo Cannula