Home GUDID M001459931 Vaxcel
Primary DI M001459931
Brand Vaxcel
Company NAVILYST MEDICAL, INC.
Model 45993
Device description Vaxcel Mini Stick Kit Coaxial Dialtor Set
Published 2016-09-20
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
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M001459931 Package HIBCC 10 In Commercial Distribution M001459930 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 4 French Length 9.4 Centimeter Needle Gauge 21 Gauge Outer Diameter 1.7 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 true 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 10884450706708 Prelude® Merit Medical Systems, Inc. DRE 2026-06-03 10884450415358 Prelude® Merit Medical Systems, Inc. DRE 2026-05-28 10841156105921 VSI TELEFLEX INCORPORATED DRE 2020-02-06 10841156105945 VSI TELEFLEX INCORPORATED DRE 2020-02-06 10841156105907 VSI TELEFLEX INCORPORATED DRE 2020-01-27 10841156105914 VSI TELEFLEX INCORPORATED DRE 2020-01-27 10841156105938 VSI TELEFLEX INCORPORATED DRE 2020-01-27 10841156105952 VSI TELEFLEX INCORPORATED DRE 2020-01-27 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 10827002237374 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10827002237466 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10827002237473 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10827002465395 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10827002465401 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10827002465418 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10884450007829 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450007867 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450007904 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008086 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008109 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008147 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008857 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008871 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008888 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008895 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008901 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24
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