DEVICE: MinXray (00861050000323)

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Device Identifier (DI) Information

MinXray
HF1202H

MINXRAY, INC.
00861050000323
GS1
1
This is a portable line operated diagnostic x-ray unit. It is a high power (4kW), heavy duty medical unit. The HF1202H complete with “High Burst” electronic function is capable of up to 120 kVDC. The input line voltage is within the range of 120V-240V (50/60Hz). It is a higher powered version of HF120/60H, which has been used by the US military for many years. It is recommended for hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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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
Portable basic diagnostic x-ray system, analogue An assembly of devices that comprise a general-purpose portable analogue diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It is typically an x-ray film based system that uses analogue or analogue-to-digital techniques for image capture and display. The portable design allows it to operate on either mains or battery power and to be easily disassembled, moved from location to another, and reassembled for use. It consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.
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FDA Product Code

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Product Code Product Code Name
IZL System, X-Ray, Mobile
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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 Humidity: between 10 and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
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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
September 01, 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
No
None
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Production Identifier(s) in UDI

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No CLOSE

Customer Contact

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1-847-564-0323
info@minxray.com
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