DEVICE: FUJIFILM (04547410330915)
Device Identifier (DI) Information
FUJIFILM
ED-530XT
In Commercial Distribution
FUJIFILM CORPORATION
ED-530XT
In Commercial Distribution
FUJIFILM CORPORATION
The Fujifilm Duodenoscope Model ED-530XT is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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36112 | Flexible video duodenoscope, reusable |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine). It is inserted into the body through the mouth during duodenoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. This device is commonly used to examine structures and mucous membranes of the duodenum for conditions like ulcers, polyps, and cancer. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FDT | duodenoscope and accessories, flexible/rigid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity |
Special Storage Condition, Specify: There must be no condensation. |
Storage Environment Temperature: between 10 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
2c3d95ca-ee55-4038-b37f-69bc541f23dd
January 23, 2019
3
December 14, 2016
January 23, 2019
3
December 14, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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14547410330912 | 1 | 04547410330915 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+018002728465
xxx@xxx.xxx
xxx@xxx.xxx