BioFlo Vortex

GUDID 15051684017015

SmartPort+ Low Profile Port with Endexo and Vortex Technology

NAVILYST MEDICAL, INC.

Vascular port/catheter

• Primary Device ID: 15051684017015
• NIH Device Record Key: 0de8e483-e6a2-4cc2-9f12-4b89254d7349
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioFlo Vortex
• Version Model Number: CT60LTBANFVI
• Company DUNS: 809699023
• Company Name: NAVILYST MEDICAL, 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(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@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
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com

Device Dimensions

• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Pressure: 300 Pound per Square Inch
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Pressure: 300 Pound per Square Inch
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Pressure: 300 Pound per Square Inch
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Pressure: 300 Pound per Square Inch
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Pressure: 300 Pound per Square Inch
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Pressure: 300 Pound per Square Inch
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Pressure: 300 Pound per Square Inch
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Pressure: 300 Pound per Square Inch
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Pressure: 300 Pound per Square Inch
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Pressure: 300 Pound per Square Inch
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Pressure: 300 Pound per Square Inch
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Pressure: 300 Pound per Square Inch
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Pressure: 300 Pound per Square Inch
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Pressure: 300 Pound per Square Inch
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Pressure: 300 Pound per Square Inch
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French
• Outer Diameter: 2.1 Millimeter
• Length: 63 Centimeter
• Catheter Gauge: 6 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684017015 [Secondary]
HIBCC	H787CT60LTBANFVI0 [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: 2020-06-08
• Device Publish Date: 2020-05-29

On-Brand Devices [BioFlo Vortex]

• 15051684016926: SmartPort+ Standard Port with Endexo and Vortex Technology
• 15051684016919: SmartPort+ Standard Port with Endexo and Vortex Technology
• 15051684016940: SmartPort+ Standard Port with Endexo and Vortex Technology
• 15051684016933: SmartPort+ Standard Port with Endexo and Vortex Technology
• 15051684017046: SmartPort+ Low Profile Port with Endexo and Vortex Technology
• 15051684017039: SmartPort+ Low Profile Port with Endexo and Vortex Technology
• 15051684016827: SmartPort+ Low Profile Port with Endexo and Vortex Technology
• 15051684017053: SmartPort Plastic Low Profile Port with Vortex Technology
• 15051684016810: SmartPort Plastic Low Profile Port with Vortex Technology
• 15051684016803: SmartPort Plastic Low Profile Port with Vortex Technology
• 15051684017206: SmartPort Plastic Low Profile Port with Vortex Technology
• 15051684017213: SmartPort Plastic Low Profile Port with Vortex Technology
• 15051684016797: SmartPort Plastic Low Profile Port with Vortex Technology
• 15051684016780: SmartPort Plastic Low Profile Port with Vortex Technology
• 15051684017220: SmartPort Plastic Low Profile Port with Vortex Technology
• 15051684017237: SmartPort Plastic Low Profile Port with Vortex Technology
• 15051684016773: SmartPort+ Low Profile Port with Endexo and Vortex Technology
• 15051684017145: SmartPort+ Low Profile Port with Endexo and Vortex Technology
• 15051684016766: SmartPort+ Low Profile Port with Endexo and Vortex Technology
• 15051684017152: SmartPort+ Low Profile Port with Endexo and Vortex Technology
• 15051684016889: SmartPort+ Standard Port with Endexo and Vortex Technology
• 15051684016872: SmartPort+ Standard Port with Endexo and Vortex Technology
• 15051684016902: SmartPort+ Standard Port with Endexo and Vortex Technology
• 15051684016896: SmartPort+ Standard Port with Endexo and Vortex Technology
• 15051684016759: SmartPort+ Mini Port with Endexo and Vortex Technology
• 15051684017084: SmartPort+ Mini Port with Endexo and Vortex Technology
• 15051684016742: SmartPort+ Mini Port with Endexo and Vortex Technology
• 15051684017091: SmartPort+ Mini Port with Endexo and Vortex Technology
• 15051684017008: SmartPort+ Low Profile Port with Endexo and Vortex Technology
• 15051684016995: SmartPort+ Low Profile Port with Endexo and Vortex Technology
• 15051684017022: SmartPort+ Low Profile Port with Endexo and Vortex Technology
• 15051684017015: SmartPort+ Low Profile Port with Endexo and Vortex Technology
• 15051684016735: SmartPort Plastic Low Profile Port with Vortex Technology
• 15051684016728: Smart Plastic Low Profile Port with Endexo and Vortex Technology
• 15051684017169: SmartPort Plastic Low Profile Port with Vortex Technology
• 15051684017176: SmartPort Plastic Low Profile Port with Vortex Technology
• 15051684016711: SmartPort Plastic Low Profile Port with Vortex Technology
• 15051684016704: SmartPort Plastic Low Profile Port with Vortex Technology
• 15051684017183: SmartPort Plastic Low Profile Port with Vortex Technology
• 15051684017190: SmartPort Plastic Low Profile Port with Vortex Technology
• 15051684016698: SmartPort+ Low Profile Port with Endexo and Vortex Technology
• 15051684017121: SmartPort+ Low Profile with Endexo and Vortex Technology
• 15051684016681: SmartPort+ Low Profile with Endexo and Vortex Technology
• 15051684017138: SmartPort+ Low Profile Port with Endexo and Vortex Technology
• 15051684016841: SmartPort+ Standard Port with Endexo and Vortex Technology
• 15051684016834: SmartPort+ Standard Port with Endexo and Vortex Technology
• H787CT50STBAVI0: SmartPort+ Standard Port with Endexo and Vortex Technology
• 15051684016674: SmartPort+ Mini Port with Endexo and Vortex Technology
• 15051684017060: SmartPort+ Mini Port with Endexo and Vortex Technology
• 15051684016667: SmartPort+ Mini Port with Endexo and Vortex Technology