Home GUDID H787124018450 Uni-Fuse+
Primary DI H787124018450
Brand Uni-Fuse+
Company Angiodynamics, Inc.
Model 12401845
Device description Uni-Fuse+ Infusion System 5F, 90cm, 5cm
Published 2020-10-30
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name KRA Catheter, continuous flush
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRA Catheter, Continuous Flush Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status H787124018450 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Peripheral vascular intervention infusion catheter A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 5 French Length 90 Centimeter Outer Diameter 1.71 Millimeter
Regulatory Flags# DUNS number 079252781 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published G4533352797GM8M50 PEAK MEDICAL Peak Medical Distribution Inc. KRA 2026-05-27 07640132622690 M-CATH Flexy Acrostak (Schweiz) AG KRA 2021-11-01 07640132622706 M-CATH Flexy Acrostak (Schweiz) AG KRA 2021-11-01 07640132622157 M-CATH Microcatheter Acrostak (Schweiz) AG KRA 2018-05-15 10351688507990 Medex ICU MEDICAL, INC. KRA 2016-12-30 10351688508669 Medex ICU MEDICAL, INC. KRA 2016-12-30 10351688505620 Medex ICU MEDICAL, INC. KRA 2016-12-29 10351688508768 Medex ICU MEDICAL, INC. KRA 2016-10-19 10351688508775 Medex ICU MEDICAL, INC. KRA 2016-10-19 10351688508782 Medex ICU MEDICAL, INC. KRA 2016-10-19 10351688508805 Medex ICU MEDICAL, INC. KRA 2016-10-19 10351688506856 Medex ICU MEDICAL, INC. KRA 2016-10-12 10351688506863 Medex ICU MEDICAL, INC. KRA 2016-10-12 10351688508898 Medex ICU MEDICAL, INC. KRA 2016-10-11 10351688509932 Medex ICU MEDICAL, INC. KRA 2016-10-11 08714729235118 Renegade™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729235125 Renegade™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280583 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280590 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280606 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280613 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280620 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280637 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280644 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280651 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280668 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280736 Renegade™ HI-FLO™ Kit BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280743 Renegade™ HI-FLO™ Kit BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280750 Renegade™ HI-FLO™ Kit BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280767 Renegade™ HI-FLO™ Kit BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24
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