PROTEK SOLO

GUDID 08033178019354

SORIN GROUP ITALIA SRL

Circulatory assist transseptal cannula

• Primary Device ID: 08033178019354
• NIH Device Record Key: ffbe8f8f-ecba-43be-a5c2-a6b3323ffa60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROTEK SOLO
• Version Model Number: 5140-6217
• 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	08033178019354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082425

FDA Product Code

• DWF: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
• DWG: ELECTROSURGICAL DEVICE

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: 2025-01-22
• Device Publish Date: 2025-01-14

On-Brand Devices [PROTEK SOLO]

• 08033178019354: 5140-6217
• 08033178019347: 5130-1717
• 08033178019330: 5130-1715
• 08033178019323: 5140-6024
• 08033178019361: 5140-6221