Home GUDID 08809887550002 EdgeFlow UH10
Primary DI 08809887550002
Brand EdgeFlow UH10
Company EdgeCare Inc.
Model UH10101
Device description Bladder volume ultrasound imaging system
Published 2024-10-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information 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 08809887550002 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08809887550002 08809887550002 8809887550002
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 Serial number true Manufacturing date on label true Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00841517112684 C5-1 FUJIFILM SONOSITE, INC. IYO 2026-08-07 00841517112684 C5-1 FUJIFILM SONOSITE, INC. ITX 2026-08-07 00860006305734 See-Mode Technologies SEE-MODE TECHNOLOGIES PTE. LTD. QIH 2026-08-07 00841436122078 Biopsy Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00841436122900 Biopsy Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00841436124294 Biopsy Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00841436125420 Tracking Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. IYO 2026-07-27 00841436125895 Needle Guide Starter Kit CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00841436126052 Biopsy Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00841436126212 Tracking Bracket Starter Kit CIVCO MEDICAL INSTRUMENTS CO., INC. IYO 2026-07-27 00841436126229 Tracking Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. IYO 2026-07-27 00841436126328 Tracking Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. IYO 2026-07-27 00841436126403 Needle Guide Starter Kit CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00841436126410 Needle Guide Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00841436126588 Tracking Bracket Starter Kit CIVCO MEDICAL INSTRUMENTS CO., INC. IYO 2026-07-27 00841436126595 Tracking Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. IYO 2026-07-27 00841436127028 Verza Guidance System CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00841436127035 Biopsy Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 10841436125311 CIV-Clear™ Transducer Cover CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 10841436125915 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 10841436125939 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 10841436125953 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 10841436127056 Cable Sleeve CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 10841436127186 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00195278713322 RIC12-D GE Healthcare Austria GmbH & Co OG IYO 2026-07-24 00195278713322 RIC12-D GE Healthcare Austria GmbH & Co OG ITX 2026-07-24 04987670106088 CONVEX ARRAY TRANSDUCER CANON INC. ITX 2026-07-24 00841436122061 Verza Guidance System CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-23 00841436122672 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. IYO 2026-07-23 00841436125338 Biopsy Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. IYO 2026-07-23