Aortic Root cannula

GUDID 38033178019638

SORIN GROUP ITALIA SRL

Cardioplegia cannula

• Primary Device ID: 38033178019638
• NIH Device Record Key: 98f6e3a5-1e3a-4d91-b7b0-21e10ec57121
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aortic Root cannula
• Version Model Number: AR-19114
• 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: true
• 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	08033178019637 [Primary]
GS1	38033178019638 [Package]; Contains: 08033178019637; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972503

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: 2026-03-16
• Device Publish Date: 2026-03-06

On-Brand Devices [Aortic Root cannula]

• 38033178019638: AR-19114
• 38033178019621: AR-13114