ENVI

GUDID H965355110

NVI MINI STICK 6F X 20CM .018 Ni/Tu .038 X 80 ROSEN-PTFE

NAVILYST MEDICAL, INC.

Vascular catheter introduction set, nonimplantable
Primary Device IDH965355110
NIH Device Record Key30065673-f29a-48fd-abc2-8a0216c037d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameENVI
Version Model Number35-510
Company DUNS809699023
Company NameNAVILYST MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
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

Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French
Lumen/Inner Diameter0.5 Millimeter
Needle Gauge21 Gauge
Length20 Centimeter
Catheter Gauge6 French

Device Identifiers

Device Issuing AgencyDevice ID
GS115051684023641 [Secondary]
HIBCCH965355110 [Primary]
HIBCCH965355111 [Package]
Package: BOX [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GBXCATHETER, IRRIGATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-06-07
Device Publish Date2017-08-07

On-Brand Devices [ENVI]

H965481040NEEDLE 18G X 15CM CHIBA STYLET ECHO TIP
H965481031NEEDLE 21G X 15CM TROCAR STYLET ECHO TIP
H965481020NEEDLE, 21G X 15CM CHIBA STYLET ECHO TIP
H965481010GUIDEWIRE, 0.018 X 65CM Ni/Tu
H965481000NVI SHEATH 6F X 20CM
H965355200NEEDLE 18G X 15 CHIBA STYLET ECHO TIP GUIDEWIRE, 0.035 X 150CM  PTFE
H965355190NEEDLE 18G X 15 CHIBA STYLET ECHO TIP GUIDEWIRE,  PTFE
H965355180NVI MINI STICK 6F X 20CM .018 Ni/Tu .035 X 150 ROSEN-PTFE
H965355170NVI MINI STICK 6F X 20CM .018 Ni/Tu .035 X 80 ROSEN-PTFE
H965355160NVI MINI STICK 6F X 20CM .018 Ni/Tu .038 X 150 ROSEN-PTFE
H965355150NVI MINI STICK 6F X 20CM .018 Ni/Tu .038 X 80 ROSEN-PTFE
H965355140NVI MINI STICK 6F X 20CM .018 Ni/Tu .035 X 150 ROSEN-PTFE
H965355130NVI MINI STICK 6F X 20CM .018 Ni/Tu .035 X 80 ROSEN-PTFE
H965355120NVI MINI STICK 6F X 20CM .018 Ni/Tu .038 X 150 ROSEN-PTFE
H965355110NVI MINI STICK 6F X 20CM .018 Ni/Tu .038 X 80 ROSEN-PTFE
H965355100STYLET 21G C 24CM SS
H965355090NVI MINI STICK 6F X 20CM 21G TROCAR ECHO
H965355080NVI MINI STICK 6F X 20CM 21G CHIBA ECHO
H965355070NVI MINI STICK 6F X 20 CM .018 Ni/Tu 21G TROCAR
H965355060NVI MINI STICK 6F X 20 CM .018 Ni/Tu 21G CHIBA ECHO TIP
H965355050NEEDLE 18G X 15CM CHIBA STYLET ECHO TIP  
H965355040NEEDLE 21G X 15CM TROCAR STYLET ECHO TIP
H965355030NEEDLE 21G X 15CM CHIBA STYLET ECHO TIP
H965355020GUIDEWIRE 0.018 X 65CM Ti/Tu
H965355010NVI SHEATH 6F X 20CM

Trademark Results [ENVI]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENVI
ENVI
98609084 not registered Live/Pending
Eheat, Inc.
2024-06-19
ENVI
ENVI
98434631 not registered Live/Pending
Advanced Aesthetics LLC
2024-03-05
ENVI
ENVI
98052478 not registered Live/Pending
The Neiders Company LLC
2023-06-21
ENVI
ENVI
97605938 not registered Live/Pending
PMK Mess- und Kommunikationstechnik GmbH
2022-09-25
ENVI
ENVI
97491149 not registered Live/Pending
Lorax Compliance Ltd
2022-07-06
ENVI
ENVI
97419384 not registered Live/Pending
Envi, LLC
2022-05-19
ENVI
ENVI
97051916 not registered Live/Pending
EnVi Enterprises
2021-09-29
ENVI
ENVI
90763585 not registered Live/Pending
Dwyer Marble & Stone Supply, Inc.
2021-06-09
ENVI
ENVI
90112268 not registered Live/Pending
NK Properties, LLC
2020-08-13
ENVI
ENVI
90035169 not registered Live/Pending
Inventory Optimization Solutions, LLC
2020-07-03
ENVI
ENVI
88850300 not registered Live/Pending
Eheat, Inc.
2020-03-27
ENVI
ENVI
88631003 not registered Live/Pending
Neurovasc Technologies Inc.
2019-09-25
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