Cardiopolmunary Bypass Cannula

GUDID 38033178019232

SORIN GROUP ITALIA SRL

Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

• Primary Device ID: 38033178019232
• NIH Device Record Key: 336ec7fe-67f0-482b-9049-710e9efc03c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiopolmunary Bypass Cannula
• Version Model Number: EasyFlow Aortic Cannula
• Company DUNS: 442126587
• Company Name: SORIN GROUP ITALIA SRL
• 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	08033178019231 [Primary]
GS1	38033178019232 [Package]; Contains: 08033178019231; Package: CASE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250610

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: 2025-12-29
• Device Publish Date: 2025-12-19

On-Brand Devices [Cardiopolmunary Bypass Cannula]

• 38033178019294: EasyFlow Duo Cannula 19FR.
• 38033178019287: EasyFlow Aortic Cannula 19FR.
• 38033178019270: EasyFlow Duo Cannula 19FR.
• 38033178019232: EasyFlow Aortic Cannula