Home GUDID 00850044140008
Helo G1 Thrombectomy System
Primary DI 00850044140008
Brand Helo G1 Thrombectomy System
Company Endovascular Engineering, Inc.
Model 20001
Published 2026-04-21
Public version status New
Distribution status 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 00850044140008 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850044140008 00850044140008 850044140008 0850044140008
GMDN Terms# Term, Definition table Term Definition Thrombectomy suction catheter A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.
Regulatory Flags# DUNS number 117560059 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850044140015 Helo Thrombectomy System HEL1595 2026-03-13
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00191506067342 TruSelect™ BOSTON SCIENTIFIC CORPORATION KRA 2026-06-01 00191506067359 TruSelect™ BOSTON SCIENTIFIC CORPORATION KRA 2026-06-01 00191506067366 TruSelect™ BOSTON SCIENTIFIC CORPORATION KRA 2026-06-01 00191506067373 TruSelect™ BOSTON SCIENTIFIC CORPORATION KRA 2026-06-01 00191506067380 TruSelect™ BOSTON SCIENTIFIC CORPORATION KRA 2026-06-01 00191506067397 TruSelect™ BOSTON SCIENTIFIC CORPORATION KRA 2026-06-01 00191506067403 TruSelect™ BOSTON SCIENTIFIC CORPORATION KRA 2026-06-01 00191506067410 TruSelect™ BOSTON SCIENTIFIC CORPORATION KRA 2026-06-01 00885403522348 SWAN-GANZ CCOMBO V Becton, Dickinson And Company KRA 2026-05-30 00885403523819 VAMP Becton, Dickinson And Company KRA 2026-05-30 00884450826492 Fountain® Merit Medical Systems, Inc. KRA 2026-05-29 00860011713135 FLOWRUNNER 7F Aspiration System, 130cm Expanse Medical, Inc. KRA 2026-05-28 00860011713159 FLOWRUNNER SP 7F Aspiration System, 130cm Expanse Medical, Inc. KRA 2026-05-28 G4533352797GM8M50 PEAK MEDICAL Peak Medical Distribution Inc. KRA 2026-05-27 15051684023801 Uni-Fuse+ Angiodynamics, Inc. KRA 2024-08-01 15051684023825 Uni-Fuse+ Angiodynamics, Inc. KRA 2024-08-01 15051684023832 Uni-Fuse+ Angiodynamics, Inc. KRA 2024-08-01 15051684023849 Uni-Fuse+ Angiodynamics, Inc. KRA 2024-08-01 15051684023856 Uni-Fuse+ Angiodynamics, Inc. KRA 2024-08-01 15051684023863 Uni-Fuse+ Angiodynamics, Inc. KRA 2024-08-01 15051684023870 Uni-Fuse+ Angiodynamics, Inc. KRA 2024-08-01 15051684023887 Uni-Fuse+ Angiodynamics, Inc. KRA 2024-08-01 15051684023894 Uni-Fuse+ Angiodynamics, Inc. KRA 2024-08-01 15051684023900 Uni-Fuse+ Angiodynamics, Inc. KRA 2024-08-01 15051684023924 Uni-Fuse+ Angiodynamics, Inc. KRA 2024-08-01 15051684023931 Uni-Fuse+ Angiodynamics, Inc. KRA 2024-08-01 15051684023948 Uni-Fuse+ Angiodynamics, Inc. KRA 2024-08-01 15051684023955 Uni-Fuse+ Angiodynamics, Inc. KRA 2024-08-01 00763000539351 Rebar Micro Therapeutics, Inc. KRA 2022-02-27 07640132622690 M-CATH Flexy Acrostak (Schweiz) AG KRA 2021-11-01