BioFlo Vortex

GUDID 15051684016858

SmartPort+ Standard Port with Endexo and Vortex Technology

Angiodynamics, Inc.

Vascular port/catheter

• Primary Device ID: 15051684016858
• NIH Device Record Key: 9897ef6b-7fca-4dbf-baf3-da6bc79928c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioFlo Vortex
• Version Model Number: CT50STBANFVI
• Company DUNS: 079252781
• Company Name: Angiodynamics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Customer Support Contacts

• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com

Device Dimensions

• Length: 45 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 45 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 45 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 45 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 45 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 45 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 45 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 45 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 45 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 45 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684016858 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190559

FDA Product Code

• LJT: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

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: 2024-11-27
• Device Publish Date: 2024-11-19

On-Brand Devices [BioFlo Vortex]

• 15051684016865: SmartPort+ Standard Port with Endexo and Vortex Technology
• 15051684016858: SmartPort+ Standard Port with Endexo and Vortex Technology