Vortex

GUDID H787P5305K0

Vortex VX Single Titanium Port System with Attached 7.2F x 53cm Silicone Catheter

NAVILYST MEDICAL, INC.

Infusion/injection port, implantable Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter Vascular port/catheter
Primary Device IDH787P5305K0
NIH Device Record Key66e9cb6c-6f9f-4c1f-bad0-242e9a7e4e7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameVortex
Version Model NumberP5305K
Company DUNS809699023
Company NameNAVILYST MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com
Phone+1(518)795-1676
Emaildgreer@angiodynamics.com

Device Dimensions

Outer Diameter2.4 Millimeter
Needle Gauge18 Gauge
Lumen/Inner Diameter1.3 Millimeter
Length53 Centimeter
Catheter Gauge7.2 French
Outer Diameter2.4 Millimeter
Needle Gauge18 Gauge
Lumen/Inner Diameter1.3 Millimeter
Length53 Centimeter
Catheter Gauge7.2 French
Outer Diameter2.4 Millimeter
Needle Gauge18 Gauge
Lumen/Inner Diameter1.3 Millimeter
Length53 Centimeter
Catheter Gauge7.2 French
Outer Diameter2.4 Millimeter
Needle Gauge18 Gauge
Lumen/Inner Diameter1.3 Millimeter
Length53 Centimeter
Catheter Gauge7.2 French
Outer Diameter2.4 Millimeter
Needle Gauge18 Gauge
Lumen/Inner Diameter1.3 Millimeter
Length53 Centimeter
Catheter Gauge7.2 French
Outer Diameter2.4 Millimeter
Needle Gauge18 Gauge
Lumen/Inner Diameter1.3 Millimeter
Length53 Centimeter
Catheter Gauge7.2 French
Outer Diameter2.4 Millimeter
Needle Gauge18 Gauge
Lumen/Inner Diameter1.3 Millimeter
Length53 Centimeter
Catheter Gauge7.2 French
Outer Diameter2.4 Millimeter
Needle Gauge18 Gauge
Lumen/Inner Diameter1.3 Millimeter
Length53 Centimeter
Catheter Gauge7.2 French
Outer Diameter2.4 Millimeter
Needle Gauge18 Gauge
Lumen/Inner Diameter1.3 Millimeter
Length53 Centimeter
Catheter Gauge7.2 French
Outer Diameter2.4 Millimeter
Needle Gauge18 Gauge
Lumen/Inner Diameter1.3 Millimeter
Length53 Centimeter
Catheter Gauge7.2 French
Outer Diameter2.4 Millimeter
Needle Gauge18 Gauge
Lumen/Inner Diameter1.3 Millimeter
Length53 Centimeter
Catheter Gauge7.2 French
Outer Diameter2.4 Millimeter
Needle Gauge18 Gauge
Lumen/Inner Diameter1.3 Millimeter
Length53 Centimeter
Catheter Gauge7.2 French
Outer Diameter2.4 Millimeter
Needle Gauge18 Gauge
Lumen/Inner Diameter1.3 Millimeter
Length53 Centimeter
Catheter Gauge7.2 French
Outer Diameter2.4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS115051684018296 [Secondary]
HIBCCH787P5305K0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LJTPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-07

On-Brand Devices [Vortex]

H787SSDX16I0Vortex TR Single Titanium Port System with Attachable 9.6F x 70cm Silicone Catheter
H787SSDX14I0Vortex TR Single Titanium Port System with Attachable 7.5F x 70cm Silicone Catheter
H787SSDX10I0Vortex TR Single Titanium Port System with Attachable 6.6F x 70cm Silicone Catheter
H787SSAX16I0Vortex TR Single Titanium Port System with Attached 9.6F x 53cm Silicone Catheter
H787SSAX14I0Vortex TR Single Titanium Port System with Attached 7.5F x 70cm Silicone Catheter
H787SPDX16I0Vortex TR Single Plastic Port System with Attachable 9.6F x 70cm Silicone Catheter
H787SPDX14I0Vortex TR Single Plastic Port System with Attachable 7.5F x 70cm Silicone Catheter
H787SPAX16I0Vortex TR Single Plastic Port System with Attached 9.6F x 53cm Silicone Catheter
H787PSDX10I0Vortex TR Low Profile Titanium Port System with Attachable 6.6F x 76cm Silicone Catheter
H787PSAX10I0Vortex TR Titanium Low Profile Implanted Port with Attached 6.6F x 76cm Silicone Catheter
H787P5455K0Vortex VX Single Titanium Port System with Attachable 9.6F x 53cm Silicone Catheter and Tray
H787P5405K0Vortex VX Single Titanium Port System with Attached 9.6F x 53cm Silicone Catheter
H787P5355K0Vortex VX Single Titanium Port System with Attachable 7.2F x 53cm Silicone Catheter
H787P5305K0Vortex VX Single Titanium Port System with Attached 7.2F x 53cm Silicone Catheter
H787MPP5SDT0Vortex MP Low Profile Titanium Port System with Attachable 5F x 76cm Silicone Catheter
H787MPP5SAT0Vortex MP Low Profile Titanium Port System with Attached 5F x 76cm Silicone Catheter
H787MPP5PT0Vortex MP Low Profile Titanium Port System with Attachable 5F x 76cm Polyurethane Catheter
H787MPP5PK0Vortex MP Low Profile Titanium Port System with Attachable 5F x 76cm Polyurethane Catheter
H787LVTX70150Vortex LP Single Plastic Port System with Attached 9.6F x 76cm Silicone Catheter
H787LVTX70130Vortex LP Single Plastic Port System with Attachable 9.6F x 76cm Silicone Catheter
H787LVTX52130Vortex LP Dual Titanium Port System with Attachable 11.4F x 76cm Silicone Catheter
H787LVTX50150Vortex LP Single Titanium Port System with Attached 9.6F x 76cm Silicone Catheter
H787LVTX50130Vortex LP Single Titanium Port System with Attachable 9.6F x 76cm Silicone Catheter
H787LVTX75130Vortex LP Single Plastic Port System with Attachable 8.4F x 76cm Polyurethane Catheter
H787LVTX55130Vortex LP Single Titanium Port System with Attachable 8.4F x 76m Polyurethane Catheter

Trademark Results [Vortex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VORTEX
VORTEX
98495268 not registered Live/Pending
Rainwater Management Solutions, Inc.
2024-04-11
VORTEX
VORTEX
98470532 not registered Live/Pending
Swiss Madison LLC
2024-03-27
VORTEX
VORTEX
98463057 not registered Live/Pending
Hughes, Albert
2024-03-22
VORTEX
VORTEX
98416098 not registered Live/Pending
Melnor, Inc.
2024-02-22
VORTEX
VORTEX
98414349 not registered Live/Pending
ALTENLOH, BRINCK & CO. US, INC.
2024-02-21
VORTEX
VORTEX
98380575 not registered Live/Pending
Rosen's, Inc.
2024-01-29
VORTEX
VORTEX
98368008 not registered Live/Pending
Tao Zhang
2024-01-21
VORTEX
VORTEX
98286304 not registered Live/Pending
Jobar International, Inc.
2023-11-27
VORTEX
VORTEX
98245004 not registered Live/Pending
Carfield, Hanna
2023-10-29
VORTEX
VORTEX
98217549 not registered Live/Pending
NLV IP, LLC
2023-10-10
VORTEX
VORTEX
98211291 not registered Live/Pending
MMLB LOGISTICS LLC
2023-10-05
VORTEX
VORTEX
98186881 not registered Live/Pending
XWireless, LLC
2023-09-19
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.