Home GUDID 00860011713166 FLOWRUNNER 12F Aspiration System, 100cm
Primary DI 00860011713166
Brand FLOWRUNNER 12F Aspiration System, 100cm
Company Expanse Medical, Inc.
Model FLWRNR10012
Catalog number FLWRNR10012
Device description The Expanse FLOWRUNNER Aspiration System is a peripheral thrombectomy system consisting of several components:- FLOWRUNNER Aspiration Catheter- FLOWRUNNER Aspiration Sheath- Vacuum Fitting- High Flow Stopcock- Y-Connector with Hemostatic Valve- Hand Actuator Clip.The FLOWRUNNER Aspiration System is designed for the minimally invasive removal of thrombus from the peripheral vasculature using aspiration. It is a single use, over-the-wire, catheter-based system. The FLOWRUNNER Aspiration System consists of one aspiration catheter, one aspiration sheath, one vacuum fitting, one high flow stopcock connector, one Y-connector with hemostatic valve, and one hand actuator clip.
Published 2026-01-12
Public version status Update
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 QEZ Aspiration Thrombectomy Catheter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRA Catheter, Continuous Flush Cardiovascular 2 QEZ Aspiration Thrombectomy Catheter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860011713166 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 00860011713166 00860011713166 860011713166 0860011713166
GMDN Terms# Term, Definition table Term Definition Thrombectomy suction catheterization kit A collection of devices intended to be used during a percutaneous transluminal thrombectomy suction procedure (in conjunction with a syringe or dedicated suction pump system) and which includes a thrombectomy suction catheter and additional devices intended to support catheter introduction and function (e.g., dilator, clot buster, haemostasis valve, aspiration tubing). This is a single-use device.
Regulatory Flags# DUNS number 118497230 Device count 1 Kit true 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 00860011713104 FLOWRUNNER 14F Aspiration System, 80cm FLWRNR08014 FLWRNR08014 2026-01-12 00860011713111 FLOWRUNNER 12F Aspiration System, 120cm FLWRNR12012 FLWRNR12012 2026-01-12 00860011713128 FLOWRUNNER 12F Aspiration System, 80cm FLWRNR08012 FLWRNR08012 2026-01-12 00860011713142 FLOWRUNNER 14F Aspiration System, 120cm FLWRNR12014 FLWRNR12014 2026-01-12 00860011713180 FLOWRUNNER 14F Aspiration System, 100cm FLWRNR10014 FLWRNR10014 2026-01-12
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