DEVICE: FUJIFILM (04547410079197)
Device Identifier (DI) Information
FUJIFILM
CA-500B
In Commercial Distribution
FUJIFILM CORPORATION
CA-500B
In Commercial Distribution
FUJIFILM CORPORATION
This product is intended to inject the reprocessing fluids during manual cleaning and manual disinfection of a FUJIFILM endoscope.
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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17662 | Flexible video bronchoscope, reusable |
An endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a reusable device.
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FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EOQ | BRONCHOSCOPE (FLEXIBLE OR 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 Atmospheric Pressure: between 70 and 106 KiloPascal |
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity |
Handling 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 |
Storage 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
3d2742d8-d43a-4ed1-af3b-c5bbce23de94
February 03, 2023
3
October 18, 2016
February 03, 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 |
---|---|---|---|---|---|
04547410331387 | 1 | 04547410079197 | 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