Vortex

GUDID H787LVTX50570

Vortex MP Titanium Low Profile Implanted Port with Attachable 5F x 76cm Silicone Catheter and Tray

ANGIODYNAMICS, INC.

Infusion/injection port, implantable

• Primary Device ID: H787LVTX50570
• NIH Device Record Key: b32d5106-270f-47d2-9a70-6cca5317b18a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vortex
• Version Model Number: LVTX5057
• Company DUNS: 601994184
• 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(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

Device Dimensions

• Length: 76 Centimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Outer Diameter: 1.7 Millimeter
• Length: 76 Centimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Outer Diameter: 1.7 Millimeter
• Length: 76 Centimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Outer Diameter: 1.7 Millimeter
• Length: 76 Centimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Outer Diameter: 1.7 Millimeter
• Length: 76 Centimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Outer Diameter: 1.7 Millimeter
• Length: 76 Centimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Outer Diameter: 1.7 Millimeter
• Length: 76 Centimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Outer Diameter: 1.7 Millimeter
• Length: 76 Centimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Outer Diameter: 1.7 Millimeter
• Length: 76 Centimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Outer Diameter: 1.7 Millimeter
• Length: 76 Centimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Outer Diameter: 1.7 Millimeter
• Length: 76 Centimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Outer Diameter: 1.7 Millimeter
• Length: 76 Centimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Outer Diameter: 1.7 Millimeter
• Length: 76 Centimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Outer Diameter: 1.7 Millimeter
• Length: 76 Centimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Outer Diameter: 1.7 Millimeter
• Length: 76 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H787LVTX50570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010767

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-17

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• H787P12155K0: Lifeport Single Plastic Vascular Access Port System with Attachable 8.4F x 76cm Polyurethane Cat
• H787P12105K0: Lifeport Single Plastic Vascular Access Port System with Attached 9.6F x 76cm Silicone Catheter
• H787LVTX55570: Vortex VX Single Titanium Port System with Attachable 9.6F x 53cm Silicone Catheter
• H787LVTX55550: Vortex VX Single Titanium Port System with Attachable 7.2F x 53cm Silicone Catheter
• H787LVTX50570: Vortex MP Titanium Low Profile Implanted Port with Attachable 5F x 76cm Silicone Catheter and Tr