Aortic-Root Cannula

GUDID 38033178004054

SORIN GROUP ITALIA SRL

Cardioplegia cannula

• Primary Device ID: 38033178004054
• NIH Device Record Key: e585150b-6915-4e7b-a769-e91901e7d02b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aortic-Root Cannula
• Version Model Number: R501-26
• 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	08033178004053 [Primary]
GS1	38033178004054 [Package]; Contains: 08033178004053; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240193

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: 2025-04-17
• Device Publish Date: 2016-03-21

On-Brand Devices [Aortic-Root Cannula]

• 38033178004054: R501-26
• 38033178004047: R501-20
• 38033178004030: R501-15
• 38033178004023: R502-26
• 38033178004016: R502-20
• 38033178004009: R502-15