BioFlo

GUDID 15051684018708

BioFlo Titanium Port with Non Filled Suture Holes and 8F x 63cm Polyurethane Catheter with ENDEXO Technology

Angiodynamics, Inc.

Vascular port/catheter

• Primary Device ID: 15051684018708
• NIH Device Record Key: e46aa8f7-7700-4305-b08c-6dab819831d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioFlo
• Version Model Number: 44017
• 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
• 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

• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 63 Centimeter
• Outer Diameter: 2.6 Millimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 63 Centimeter
• Outer Diameter: 2.6 Millimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 63 Centimeter
• Outer Diameter: 2.6 Millimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 63 Centimeter
• Outer Diameter: 2.6 Millimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 63 Centimeter
• Outer Diameter: 2.6 Millimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 63 Centimeter
• Outer Diameter: 2.6 Millimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 63 Centimeter
• Outer Diameter: 2.6 Millimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 63 Centimeter
• Outer Diameter: 2.6 Millimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 63 Centimeter
• Outer Diameter: 2.6 Millimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 63 Centimeter
• Outer Diameter: 2.6 Millimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 63 Centimeter
• Outer Diameter: 2.6 Millimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 63 Centimeter
• Outer Diameter: 2.6 Millimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 63 Centimeter
• Outer Diameter: 2.6 Millimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 63 Centimeter
• Outer Diameter: 2.6 Millimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 63 Centimeter
• Outer Diameter: 2.6 Millimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 63 Centimeter
• Outer Diameter: 2.6 Millimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 63 Centimeter
• Outer Diameter: 2.6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684018708 [Primary]
HIBCC	H965440170 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131694

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: 2024-09-30
• Device Publish Date: 2024-09-20

On-Brand Devices [BioFlo]

• 15051684018784: BioFlo Dual Port with Endexo Technology - Plastic Port with Filled Suture Holes and 8F Polyureth
• 15051684018777: BioFlo Dual Port with Endexo Technology - Plastic Port with Non-Filled Suture Holes and 8F Polyu
• 15051684018753: BioFlo Titanium Port with PASV Valve Technology (Non-Filled Suture Holes) and 6F x 63cm Polyure
• 15051684018746: BioFlo Plastic Port with PASV Valve Technology (Filled Suture Holes) and 8F x 63cm Polyurethane
• 15051684018708: BioFlo Titanium Port with Non Filled Suture Holes and 8F x 63cm Polyurethane Catheter with ENDEX
• 15051684018692: BioFlo Titanium Port with Non Filled Suture Holes and 6F x 63cm Polyurethane Catheter with ENDEX