DEVICE: FUJIFILM (04547410323856)
Device Identifier (DI) Information
FUJIFILM
EC-530HL2
In Commercial Distribution
FUJIFILM CORPORATION
EC-530HL2
In Commercial Distribution
FUJIFILM CORPORATION
This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. This device may be used on adults, adolescents and children requiring endoscopic examination and as deemed appropriate by trained medical professionals.
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? |
---|---|---|---|---|
36117 | Flexible video colonoscope, reusable |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are transmitted to a monitor for viewing by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope. This device is commonly used to examine the lining of the colon or to evaluate altered bowel habits, colonic cancer, polyps, diverticular disease, occult or frank blood in stools, or unexplained anaemia. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FDF | Colonoscope and accessories, flexible/rigid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K112391 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: There must be no condensation. |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity |
Storage Environment Temperature: between 10 and 40 Degrees Celsius |
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
25b7c25f-1704-441d-a6ae-fa6cc41f08b0
December 11, 2023
3
December 14, 2016
December 11, 2023
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 |
---|---|---|---|---|---|
14547410323853 | 1 | 04547410323856 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
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