DEVICE: Bladder Scanner (06940912714012)

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Device Identifier (DI) Information

Bladder Scanner
PBS V4.1

Mianyang Meike Electronic Equipment Co., Ltd.
06940912714012
GS1
1
PBS V4.1 Bladder Scanner is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The device consists of host and probe, it can speedily complete the detection of bladder area through scan of probe connected with the device, and transmit B ultrasound echo signal detected to embedded computer system after processing before computer identifies the edge of image and volume calculation, realizes the measurement of bladder volume, displays and prints out the relative information through LED/built-in printer. It is intended to project ultrasound energy through thle lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindlicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wotund and skin disease.
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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 ultrasound imaging system, battery-powered A battery-powered, hand-held assembly of devices designed for collection, display, and analysis of ultrasound information during a variety of extracorporeal ultrasound imaging procedures (i.e., non-dedicated); it is not intended for intracorporeal ultrasound imaging. It typically consists of an ultrasound transducer, data processing unit, and graphical display contained within a compact unit, and may include a line-powered charging station.
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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
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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 Status

In Commercial Distribution
August 18, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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