DEVICE: UNEX (04573349040069)

Device Identifier (DI) Information

UNEX
UNEXEF-38G
In Commercial Distribution

UNEX CORPORATION
04573349040069
GS1

1
697250967 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
ITX Transducer, Ultrasonic, Diagnostic
IYO System, Imaging, Pulsed Echo, Ultrasonic
IYN System, Imaging, Pulsed Doppler, Ultrasonic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131973 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

b1df9e47-da8e-4924-8775-8df1ab5f4e6a
July 06, 2018
4
November 29, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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