Home GUDID M001459841 Vaxcel
Primary DI M001459841
Brand Vaxcel
Company NAVILYST MEDICAL, INC.
Model 45984
Device description Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 5F x 10cm Catheter, and Radiopaque Tip
Published 2015-09-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION LDF ELECTRODE, PACEMAKER, TEMPORARY
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular 2 LDF Electrode, Pacemaker, Temporary Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M001459841 Package HIBCC 10 In Commercial Distribution M001459840 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Vascular catheter introduction set, nonimplantable A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 5 French Length 10 Centimeter Lumen/Inner Diameter 0.5 Millimeter Needle Gauge 21 Gauge Outer Diameter 1.8 Millimeter
Regulatory Flags# DUNS number 809699023 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10884450415631 Prelude® Merit Medical Systems, Inc. DRE 2026-07-08 10884450415655 Prelude® Merit Medical Systems, Inc. DRE 2026-07-08 10884450707781 Prelude® Merit Medical Systems, Inc. DRE 2026-07-08 00884450860342 Merit S-MAK™ Merit Medical Systems, Inc. DRE 2026-06-25 00884450468340 Merit MAK™ Merit Medical Systems, Inc. DRE 2026-06-23 10884450706708 Prelude® Merit Medical Systems, Inc. DRE 2026-06-03 10884450415358 Prelude® Merit Medical Systems, Inc. DRE 2026-05-28 08886483507166 Bipolar Pacing Catheter BIOPTIMAL INTERNATIONAL PTE. LTD. LDF 2026-05-04 08714729295822 NA BOSTON SCIENTIFIC CORPORATION DRE 2016-09-24 08714729295839 NA BOSTON SCIENTIFIC CORPORATION DRE 2016-09-24 08714729295853 NA BOSTON SCIENTIFIC CORPORATION DRE 2016-09-24 08714729375555 NA BOSTON SCIENTIFIC CORPORATION DRE 2016-09-24 08714729742913 NA BOSTON SCIENTIFIC CORPORATION DRE 2016-09-24 H787181002010 AngioDynamics ANGIODYNAMICS, INC. DRE 2016-09-20 H787181002030 AngioDynamics ANGIODYNAMICS, INC. DRE 2016-09-20 H787181002040 AngioDynamics ANGIODYNAMICS, INC. DRE 2016-09-20 H965457480 AngioDynamics NAVILYST MEDICAL, INC. DRE 2016-09-20 H965457490 AngioDynamics NAVILYST MEDICAL, INC. DRE 2016-09-20 H965457500 AngioDynamics NAVILYST MEDICAL, INC. DRE 2016-09-20 H965457510 AngioDynamics NAVILYST MEDICAL, INC. DRE 2016-09-20 H965457520 AngioDynamics NAVILYST MEDICAL, INC. DRE 2016-09-20 H965457530 AngioDynamics NAVILYST MEDICAL, INC. DRE 2016-09-20 H965457540 AngioDynamics NAVILYST MEDICAL, INC. DRE 2016-09-20 H965457550 AngioDynamics NAVILYST MEDICAL, INC. DRE 2016-09-20 H965457560 AngioDynamics NAVILYST MEDICAL, INC. DRE 2016-09-20 H965457570 AngioDynamics NAVILYST MEDICAL, INC. DRE 2016-09-20 H965457580 AngioDynamics NAVILYST MEDICAL, INC. DRE 2016-09-20 H965457590 AngioDynamics NAVILYST MEDICAL, INC. DRE 2016-09-20 H965457600 AngioDynamics NAVILYST MEDICAL, INC. DRE 2016-09-20 H965457610 AngioDynamics NAVILYST MEDICAL, INC. DRE 2016-09-20
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