DEVICE: FUJIFILM (04547410331103)

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Device Identifier (DI) Information

FUJIFILM
XL-4450

FUJIFILM CORPORATION
04547410331103
GS1
1
The XL-4450 light source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air and water through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, video processor, monitor, recorder and various peripheral devices.
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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
Endoscopic light source, line-powered A mains electricity (AC-powered) device that provides light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes, e.g., arthroscopes, cystoscopes, laparoscopes, gastroscopes. It provides a source of bright light [e.g., typically using a xenon (Xe) light bulb] that is channelled via a light cable connecting this device to the endoscope to illuminate the site of observation/intervention while minimizing tissue heating.
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FDA Product Code

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Product Code Product Code Name
GCT Light source, endoscope, xenon arc
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Sterilization

No
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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 Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 30 and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify: There must be no condensation.
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 45 Degrees Celsius
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
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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 16, 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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None
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Production Identifier(s) in UDI

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Yes
No CLOSE

Customer Contact

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+1(800)272-8465
xxx@xxx.xxx
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