DEVICE: SIUI (06938396410001)

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Device Identifier (DI) Information

SIUI
Apogee 1000

Shantou Institute of Ultrasonic Instruments Co., Ltd.
06938396410001
GS1
1
Digital Color Doppler Ultrasound Imaging System
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

GMDN

[?]

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
IYN System, Imaging, Pulsed Doppler, Ultrasonic
IYO System, Imaging, Pulsed Echo, Ultrasonic
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Sterilization

No
No
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
July 14, 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
No Secondary DIs found
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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