Vaxcel

GUDID M001459811

Vaxcel Mini Stick Kit Coaxial Dialtor Set

NAVILYST MEDICAL, INC.

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable
Primary Device IDM001459811
NIH Device Record Key90bc3520-dc2c-4667-bff5-b45fdf767d79
Commercial Distribution StatusIn Commercial Distribution
Brand NameVaxcel
Version Model Number45981
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 Latextrue
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

Device Dimensions

Outer Diameter1.5 Millimeter
Length9.4 Centimeter
Needle Gauge21 Gauge
Catheter Gauge4 French
Outer Diameter1.5 Millimeter
Length9.4 Centimeter
Needle Gauge21 Gauge
Catheter Gauge4 French
Outer Diameter1.5 Millimeter
Length9.4 Centimeter
Needle Gauge21 Gauge
Catheter Gauge4 French
Outer Diameter1.5 Millimeter
Length9.4 Centimeter
Needle Gauge21 Gauge
Catheter Gauge4 French
Outer Diameter1.5 Millimeter
Length9.4 Centimeter
Needle Gauge21 Gauge
Catheter Gauge4 French
Outer Diameter1.5 Millimeter
Length9.4 Centimeter
Needle Gauge21 Gauge
Catheter Gauge4 French
Outer Diameter1.5 Millimeter
Length9.4 Centimeter
Needle Gauge21 Gauge
Catheter Gauge4 French
Outer Diameter1.5 Millimeter
Length9.4 Centimeter
Needle Gauge21 Gauge
Catheter Gauge4 French
Outer Diameter1.5 Millimeter
Length9.4 Centimeter
Needle Gauge21 Gauge
Catheter Gauge4 French
Outer Diameter1.5 Millimeter
Length9.4 Centimeter
Needle Gauge21 Gauge
Catheter Gauge4 French
Outer Diameter1.5 Millimeter
Length9.4 Centimeter
Needle Gauge21 Gauge
Catheter Gauge4 French
Outer Diameter1.5 Millimeter
Length9.4 Centimeter
Needle Gauge21 Gauge
Catheter Gauge4 French
Outer Diameter1.5 Millimeter
Length9.4 Centimeter
Needle Gauge21 Gauge
Catheter Gauge4 French
Outer Diameter1.5 Millimeter
Length9.4 Centimeter
Needle Gauge21 Gauge
Catheter Gauge4 French
Outer Diameter1.5 Millimeter
Length9.4 Centimeter
Needle Gauge21 Gauge
Catheter Gauge4 French
Outer Diameter1.5 Millimeter
Length9.4 Centimeter
Needle Gauge21 Gauge
Catheter Gauge4 French
Outer Diameter1.5 Millimeter
Length9.4 Centimeter
Needle Gauge21 Gauge
Catheter Gauge4 French
Outer Diameter1.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM001459810 [Primary]
HIBCCM001459811 [Package]
Contains: M001459810
Package: BOX [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2016-09-20

On-Brand Devices [Vaxcel]

M001459941Vaxcel Mini Stick Kit Coaxial Dialtor Set
M001459931Vaxcel Mini Stick Kit Coaxial Dialtor Set
M001459921Vaxcel Mini Stick Kit Coaxial Dialtor Set
M001459911Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 6F x 10cm Catheter, NiTi Guidewire, a
M001459901Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 5F x 10cm Catheter, NiTi Guidewire, a
M001459891Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 4.5F x 10cm Catheter, NiTi Guidewire,
M001459881Vaxcel Mini Stick Kit Coaxial Dialtor Set
M001459871Vaxcel Mini Stick Kit Coaxial Dialtor Set
M001459861Vaxcel Mini Stick Kit Coaxial Dialtor Set
M001459851Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 6F x 10cm Catheter, and Radiopaque Ti
M001459841Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 5F x 10cm Catheter, and Radiopaque Ti
M001459821Vaxcel Mini Stick Kit Coaxial Dialtor Set
M001459811Vaxcel Mini Stick Kit Coaxial Dialtor Set
M001459801Vaxcel Mini Stick Kit Coaxial Dialtor Set
H96560M0800421PICC Convenience Kit
H96560M0800411PICC Convenience Kit
H96560M0307031PICC Convenience Kit
H96560M0307021PICC Convenience Kit
H96560M0307011PICC Convenience Kit
H96560M0169621PICC Convenience Kit
H965454370Vaxcel PICC with PASV Valve - 3F x 60cm Polyurethane Catheter Intermediate MST Kit
H965454360Vaxcel PICC with PASV Valve - 3F x 60cm Polyurethane Catheter MST-60 Kit
H965454350Vaxcel PICC with PASV Valve - 3F x 60cm Polyurethane Catheter Kit
M001455980Vaxcel PICC with PASV Valve - 5F x 60cm Polyurethane Catheter Intermediate MST Kit
M001455940Vaxcel PICC with PASV Valve - 4F x 60cm Polyurethane Catheter Intermediate MST Kit
M001454790Vaxcel PICC with PASV Valve - 6F x 60cm Dual Lumen Polyurethane Catheter MST-60 Kit
M001454780Vaxcel PICC with PASV Valve - 6F x 60cm Dual Lumen Polyurethane Catheter IR-145 Kit
M001454770Vaxcel PICC with PASV Valve - 6F x 60cm Dual Lumen Polyurethane Catheter MST-30 Kit
M001454740Vaxcel PICC with PASV Valve - 5F x 60cm Dual Lumen Polyurethane Catheter MST-60 Kit
M001454730Vaxcel PICC with PASV Valve - 5F x 60cm Dual Lumen Polyurethane Catheter IR-145 Kit
M001454710Vaxcel PICC with PASV Valve - 5F x 60cm Dual Lumen Polyurethane Catheter Introducer Kit
M001454700Vaxcel PICC with PASV Valve - 5F x 60cm Polyurethane Catheter Kit
M001454640Vaxcel PICC with PASV Valve - 5F x 60cm Polyurethane Catheter MST-60 Kit
M001454630Vaxcel PICC with PASV Valve - 5F x 60cm Polyurethane Catheter IR-145 Kit
M001454620Vaxcel PICC with PASV Valve - 5F x 60cm Polyurethane Catheter MST-30 Kit
M001454610Vaxcel PICC with PASV Valve - 5F x 60cm Polyurethane Catheter Introducer Kit
M001454580Vaxcel PICC with PASV Valve - 4F x 60cm Polyurethane Catheter IR-145 Kit
M001454570Vaxcel PICC with PASV Valve - 4F x 60cm Polyurethane Catheter MST-30 Kit
M001454560Vaxcel PICC with PASV Valve - 4F x 60cm Polyurethane Catheter Introducer Kit
M001454550Vaxcel PICC with PASV Valve - 4F x 60cm Polyurethane Catheter Kit
M001454720Vaxcel PICC with PASV Valve - 5F x 60cm Dual Lumen Polyurethane Catheter MST-30 Kit
M001454590Vaxcel PICC with PASV Valve - 4F x 60cm Polyurethane Catheter MST-60 Kit
M0014558409in Vaxcel Plus Chronic Dialysis Catheter Plastic Tunneler
M0014558309in Vaxcel Plus Chronic Dialysis Catheter Metal Tunneler
M00145559014.5F x 50cm Vaxcel Plus Chronic Dialysis Catheter with Plastic Tunneler and 3 Introducer Needle
M00145558014.5F x 50cm Vaxcel Plus Chronic Dialysis Catheter with Metal Tunneler and 3 Introducer Needle S
M00145557014.5F x 50cm Vaxcel Plus Chronic Dialysis Catheter with Plastic Tunneler
M00145556014.5F x 50cm Vaxcel Plus Chronic Dialysis Catheter with Metal Tunneler
M00145555014.5F x 37cm Vaxcel Plus Chronic Dialysis Catheter with Plastic Tunneler and 3 Introducer Needle
M00145554014.5F x 37cm Vaxcel Plus Chronic Dialysis Catheter with Metal Tunneler and 3 Introducer Needle S

Trademark Results [Vaxcel]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VAXCEL
VAXCEL
86303096 4671164 Live/Registered
VAXCEL INTERNATIONAL CO., LTD.
2014-06-06
VAXCEL
VAXCEL
78387758 3319458 Live/Registered
NAVILYST MEDICAL, INC.
2004-03-19
VAXCEL
VAXCEL
75592102 2669464 Live/Registered
NAVILYST MEDICAL, INC.
1998-08-20
VAXCEL
VAXCEL
74358461 not registered Dead/Abandoned
VAXCEL, INC.
1993-02-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.