DEVICE: FUJIFILM (04547410331592)

Device Identifier (DI) Information

FUJIFILM
GW-100
In Commercial Distribution

FUJIFILM CORPORATION
04547410331592
GS1

1
713565195 *Terms of Use
This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm’s endoscopy system.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Gastrointestinal endoscopic insufflator A mains electricity (AC-powered) device intended to be used during an endoscopic procedure to distend (expand by pressure) the lumen of the colon or other portion of the gastrointestinal (GI) tract, and/or improve endoscopic visualization (e.g., prevent dew/mist accumulating at the lens) through the pressure-limited introduction of medical gas [e.g., carbon dioxide (CO2)]. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. This device may also be referred to as a gas distention system.
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FDA Product Code

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Product Code Product Code Name
FCX INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -10 and 45 Degrees Celsius
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Humidity: between 30 and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify: There must be no condensation.
Handling Environment Temperature: between 10 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

1ff8f473-7747-493a-a961-27b82e461271
March 29, 2018
2
December 14, 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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+1(800)272-8465
xxx@xxx.xxx
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