Home GUDID 08809887550187 EdgeFlow UH10E
Primary DI 08809887550187
Brand EdgeFlow UH10E
Company EdgeCare Inc.
Model UH10101E
Device description Bladder volume ultrasound imaging system
Published 2026-09-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name ITX Transducer, Ultrasonic, Diagnostic IYO System, Imaging, Pulsed Echo, Ultrasonic QIH Automated Radiological Image Processing Software
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ITX Transducer, Ultrasonic, Diagnostic Radiology 2 IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology 2 QIH Automated Radiological Image Processing Software Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08809887550187 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08809887550187 08809887550187 8809887550187
GMDN Terms# Term, Definition table Term Definition Bladder volume ultrasound imaging system An assembly of portable, battery-powered devices designed for the extracorporeal ultrasound measurement of the male or female urinary bladder volume. It typically consists of an electronic measuring and imaging display unit with a connected ultrasound transducer which together reproduce digitized data of the bladder, typically bladder volume and post-void residual (PVR), and images. It will generate ultrasound pulses, direct them to a the target area, detect the ultrasound echoes, and process the resulting information to produce and display static or dynamic three-dimensional (3-D) data/images. It is used in the diagnosis of urinary retention and postoperative urinary retention (POUR).
Regulatory Flags# DUNS number 695523164 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00841517112776 Sonosite MT FUJIFILM SONOSITE, INC. ITX 2026-10-26 00841517112776 Sonosite MT FUJIFILM SONOSITE, INC. IYO 2026-10-26 00860013056506 Cirrus Software Application SORA NEUROSCIENCE, INC. QIH 2026-10-26 07070554100863 Medistim QuickFit TTFM probe Medistim ASA ITX 2026-10-26 07070554100870 Medistim QuickFit TTFM probe Medistim ASA ITX 2026-10-26 07070554100887 Medistim QuickFit TTFM probe Medistim ASA ITX 2026-10-26 07070554100894 Medistim QuickFit TTFM probe Medistim ASA ITX 2026-10-26 07070554100900 Medistim QuickFit TTFM probe Medistim ASA ITX 2026-10-26 00850018318020 Bladder AI Exo Imaging, Inc. QIH 2026-10-22 00850018318075 AI Platform II Exo Imaging, Inc. QIH 2026-10-22 00850018318082 Strain AI Exo Imaging, Inc. QIH 2026-10-22 03770033463055 FETOLY DIAGNOLY QIH 2026-10-22 03770033463055 FETOLY DIAGNOLY IYO 2026-10-22 05745000308361 Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual Ex Cercare Medical A/S QIH 2026-10-16 19356870000069 PHA 4DMEDICAL LIMITED QIH 2026-10-13 00198953083246 Voluson GE Healthcare Austria GmbH & Co OG QIH 2026-10-09 00198953083246 Voluson GE Healthcare Austria GmbH & Co OG IYO 2026-10-09 00198953083246 Voluson GE Healthcare Austria GmbH & Co OG ITX 2026-10-09 00198953083253 Voluson GE Healthcare Austria GmbH & Co OG ITX 2026-10-09 00198953083253 Voluson GE Healthcare Austria GmbH & Co OG QIH 2026-10-09 00198953083253 Voluson GE Healthcare Austria GmbH & Co OG IYO 2026-10-09 00198953083260 Voluson GE Healthcare Austria GmbH & Co OG IYO 2026-10-09 00198953083260 Voluson GE Healthcare Austria GmbH & Co OG ITX 2026-10-09 00198953083260 Voluson GE Healthcare Austria GmbH & Co OG QIH 2026-10-09 06948941160022 Bladder Scanner Meda Co., Ltd ITX 2026-10-08 06948941160022 Bladder Scanner Meda Co., Ltd IYO 2026-10-08 00198953200421 EchoPAC GE Vingmed Ultrasound A/S QIH 2026-10-07 00198953200438 EchoPAC GE Vingmed Ultrasound A/S QIH 2026-10-07 04262352357645 DS Core Diagnosis Zetta25 AG QIH 2026-10-06 00860006442651 cmAngio Curemetrix, Inc. QIH 2026-10-05