Hub

Basic Information

• Brand Name: Hub
• Primary DI: 09353278000069
• Version / Model: P005324
• Company Name: ECHONOUS, INC.
• Labeler DUNS: 080481089
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-09
• Public Version: 3
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 9f821026-174b-4994-815e-473d0b841ba4

Device Description

An electronic unit that supports switching between multiple transducers, and charging of the display tablet and transducers.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62345	Ultrasound imaging system multi-transducer connection unit	An electronic device intended to be used with an ultrasound (US) imaging system to enable the simultaneous connection of multiple hand-held US transducers so the user can conveniently switch between transducers as required. It is a unit with multiple transducer ports and is typically attached to the US imaging system stand.	No	Active
32547	Medical networking interface unit	An electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09353278000069	GS1

Premarket Submissions

Submission Number	Supplement Number
K181574	000