DEVICE: FUJIFILM (04547410111408)
Device Identifier (DI) Information
FUJIFILM
BA-BU1
In Commercial Distribution
FUJIFILM CORPORATION
BA-BU1
In Commercial Distribution
FUJIFILM CORPORATION
This product is intended to attach the balloon to the distal end of FUJIFILM ultrasound bronchoscope.
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? |
---|---|---|---|---|
44921 | Flexible ultrasound bronchoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the trachea, bronchi, and lungs. It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by the device typically through a fibreoptic bundle or a video system, and an ultrasound probe. The probe may be built-in or inserted through a dedicated lumen so that its distal tip is positioned adjacent to that of the endoscope. It is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K121035 | 000 |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
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Moist Heat or Steam Sterilization |
Ethylene Oxide |
High-level Disinfectant |
Storage and Handling
[?]Storage and Handling |
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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 |
Storage Environment Temperature: between 10 and 40 Degrees Celsius |
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Special Storage Condition, Specify: There must be no condensation. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
75fe7ffa-2da4-4fc0-8ada-3687d75cd5d7
December 11, 2023
3
October 18, 2016
December 11, 2023
3
October 18, 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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No Package DIs found |
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