Home GUDID 07290018579053 Pulsenmore ES Tera
Primary DI 07290018579053
Brand Pulsenmore ES Tera
Company PULSENMORE LTD
Model 400-0005
Catalog number 400-0005
Device description Ultrasound imaging system for acquiring images at home by lay users
Published 2026-02-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name SGJ Ultrasound Imaging System For Acquiring Images At Home By Lay Users
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class SGJ Ultrasound Imaging System For Acquiring Images At Home By Lay Users Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290018579053 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290018579053 07290018579053 7290018579053
GMDN Terms# Term, Definition table Term Definition Hand-held ultrasound imaging system, body-surface A battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into the vagina or rectum.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Handling Environment Humidity 15 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Temperature -20 Degrees Celsius 50 Degrees Celsius Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 15 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 600380074 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07290018579008 Pulsenmore ES Type C 400-0001 400-0001 2025-11-25 07290018579039 Pulsenmore ES Type iOS 400-0003 400-0003 2025-11-25
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07290018579008 Pulsenmore ES Type C PULSENMORE LTD SGJ 2025-11-25 07290018579039 Pulsenmore ES Type iOS PULSENMORE LTD SGJ 2025-11-25