Mobile Stand

GUDID 09353278000052

Radiological imaging system transport kit

ECHONOUS, INC.

Radiological imaging system transport kit
Primary Device ID09353278000052
NIH Device Record Key1e502222-3839-42d7-9026-2359bfa7b35b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMobile Stand
Version Model NumberP005149
Company DUNS080481089
Company NameECHONOUS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109353278000052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-12
Device Publish Date2018-08-09

Devices Manufactured by ECHONOUS, INC.

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09353278000663 - EchoNous Samsung S8 Tablet with Software2023-03-16 EchoNous (Uscan) Samsung S8 Tablet with Software
09353278000670 - EchoNous Samsung S8 Tablet with Software (Refurbished)2023-03-16 EchoNous (Uscan) Samsung S8 Tablet with Software (Refurbished)
09353278000717 - Kosmos OTS iOS Software Package2023-03-14 Kosmos OTS iOS Software Package
09353278000700 - Kosmos OTS Android Doppler Software Package2023-02-13 Kosmos OTS Android Doppler Software Package
09353278000687 - Kosmos OTS Android Linear2022-09-14 Kosmos on Android software application for ultrasound imaging

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