Home GUDID 00850044140039 Helo Return Blood Return System
Primary DI 00850044140039
Brand Helo Return Blood Return System
Company Endovascular Engineering, Inc.
Model HELRET1
Published 2026-10-19
Public version status New
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 SHJ Thrombectomy Whole Blood Return System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class SHJ Thrombectomy Whole Blood Return System
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850044140039 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 00850044140039 00850044140039 850044140039 0850044140039
GMDN Terms# Term, Definition table Term Definition Autotransfusion system blood collection container A receptacle intended to be used for the collection of autologous blood from a patient in conjunction with a dedicated pump and tubing set (not included) as part of an autotransfusion procedure. It typically includes a lid and short connection tubing. This is a single-use device.
Regulatory Flags# DUNS number 117560059 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850044140022 Helo Max Thrombectomy System HEL2090 2026-09-29 00850044140008 Helo G1 Thrombectomy System 20001 2026-04-21 00850044140015 Helo Thrombectomy System HEL1595 2026-03-13