UNEX

Basic Information

• Brand Name: UNEX
• Primary DI: 04573349040069
• Version / Model: UNEXEF-38G
• Company Name: UNEX CORPORATION
• Labeler DUNS: 697250967
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-29
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b1df9e47-da8e-4924-8775-8df1ab5f4e6a

Device Description

The UNEXEF-38G Ultrasound System is a portable,software controlled ultrasound system used to acquire and display high resolution, real time ultrasound data in a variety of modes and clinical settings. This system is Track 3 device that employs an ultrasound probe consisting of ultrasonic transducers arranged in a comb, whereby ultrasound can be generated by supplying electric pulse signals to a group of transducers consisting of multiple adjacent transducers in the single probe.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	892.1550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40761	General-purpose ultrasound imaging system	A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04573349040069	GS1

Premarket Submissions

Submission Number	Supplement Number
K131973	000