Venous Cannula

GUDID 38033178000049

SORIN GROUP ITALIA SRL

Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous

• Primary Device ID: 38033178000049
• NIH Device Record Key: 6bd3aa10-109e-479c-9a98-12fc2584adb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venous Cannula
• Version Model Number: V122-20
• 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	08033178000048 [Primary]
GS1	38033178000049 [Package]; Contains: 08033178000048; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861496

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: 2022-08-05
• Device Publish Date: 2016-03-21

On-Brand Devices [Venous Cannula]

• 38033178000247: V112-50
• 38033178000230: V112-40
• 38033178000223: V112-32
• 38033178000179: V152-36
• 38033178000162: V152-32
• 38033178000100: V122-36
• 38033178000094: V122-34
• 38033178000087: V122-32
• 38033178000070: V122-28
• 38033178000063: V122-24
• 38033178000056: V122-22
• 38033178000049: V122-20
• 38033178000032: V122-18
• 38033178000025: V122-16
• 38033178000018: V122-14