DEVICE: FUJIFILM (04547410339420)

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Device Identifier (DI) Information

FUJIFILM
AW-601

FUJIFILM CORPORATION
04547410339420
GS1
1
This product is the suction button used in combination with our endoscopes in medical facilities.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Endoscopic air/water valve, reusable A non-sterile device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] and/or water whilst preventing backflow. It is in the form of an attachable valve with one or more settings such as closed, insufflation (allowing air/gas in), and irrigation/rinse (allowing water in). This is a reusable device intended to be reprocessed prior to use.
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FDA Product Code

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Product Code Product Code Name
FFY Adaptor, bulbs, miscellaneous, for endoscope
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Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization
High-level Disinfectant
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling 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 Humidity: between 30 and 85 Percent (%) Relative Humidity
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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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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+018002728465
xxx@xxx.xxx
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