DEVICE: WHALE (06970528550018)

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Device Identifier (DI) Information

WHALE
DigiArc 100AU

Beijing East Whale Imaging Technology Co., Ltd.
06970528550018
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
No
Yes
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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
Mobile general-purpose fluoroscopic x-ray system, digital A mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be both real-time and delayed formats.
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FDA Product Code

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Product Code Product Code Name
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
JAA System, X-Ray, Fluoroscopic, Image-Intensified
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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
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
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Clinically Relevant Size

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Size Type Text
Weight: 600 Kilogram
Width: 922 Millimeter
Length: 2234 Millimeter
Height: 2540 Millimeter
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Device Status

In Commercial Distribution
September 04, 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)

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No
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None
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Production Identifier(s) in UDI

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No
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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