DEVICE: ECOMAX (04260502640012)

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Device Identifier (DI) Information

ECOMAX
1186
1186-3-4000
PROTEC GmbH & Co. KG
04260502640012
GS1
1
Darkroom automated x-ray film processor
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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
Darkroom automated x-ray film processor A mains electricity (AC-powered) automated darkroom film processing device in which x-ray/radiographic film must be manually removed from a cassette and loaded into the processor in a darkroom setting. It is designed to transport x-ray or radiographic film from one solution to the next in the developing process without any manual labour except the insertion of the film. It has typically six main sub-systems: transport, temperature, circulation, replenishment, drying and electrical control.
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FDA Product Code

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Product Code Product Code Name
IXW Processor, Radiographic-Film, Automatic
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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
Handling Environment Humidity: between 50 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 18 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
October 28, 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
None
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Production Identifier(s) in UDI

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Yes
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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