FUJIFILM

GUDID 14547410500643

FUJIFILM Endoscope Model EG-840N is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. This product can be inserted orally or nasally. Never use this product for any other purposes.

FUJIFILM CORPORATION

Flexible video gastroduodenoscope
Primary Device ID14547410500643
NIH Device Record Key1b0cd9ba-33a8-427f-bb19-dfdbe3c4f0de
Commercial Distribution StatusIn Commercial Distribution
Brand NameFUJIFILM
Version Model NumberEG-840N
Company DUNS713565195
Company NameFUJIFILM CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *no dew condensation
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *no dew condensation
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *no dew condensation
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *no dew condensation
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *no dew condensation
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *no dew condensation
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *no dew condensation
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *no dew condensation
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *no dew condensation
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *no dew condensation
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *no dew condensation
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *no dew condensation
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *no dew condensation
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *no dew condensation
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *no dew condensation
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *no dew condensation
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *no dew condensation

Device Identifiers

Device Issuing AgencyDevice ID
GS104547410500646 [Primary]
GS114547410500643 [Package]
Contains: 04547410500646
Package: Box [1 Units]
In Commercial Distribution

FDA Product Code

FDSGastroscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[14547410500643]

High-level Disinfectant;Ethylene Oxide


[14547410500643]

High-level Disinfectant;Ethylene Oxide


[14547410500643]

High-level Disinfectant;Ethylene Oxide


[14547410500643]

High-level Disinfectant;Ethylene Oxide


[14547410500643]

High-level Disinfectant;Ethylene Oxide


[14547410500643]

High-level Disinfectant;Ethylene Oxide


[14547410500643]

High-level Disinfectant;Ethylene Oxide


[14547410500643]

High-level Disinfectant;Ethylene Oxide


[14547410500643]

High-level Disinfectant;Ethylene Oxide


[14547410500643]

High-level Disinfectant;Ethylene Oxide


[14547410500643]

High-level Disinfectant;Ethylene Oxide


[14547410500643]

High-level Disinfectant;Ethylene Oxide


[14547410500643]

High-level Disinfectant;Ethylene Oxide


[14547410500643]

High-level Disinfectant;Ethylene Oxide


[14547410500643]

High-level Disinfectant;Ethylene Oxide


[14547410500643]

High-level Disinfectant;Ethylene Oxide


[14547410500643]

High-level Disinfectant;Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-30
Device Publish Date2024-09-20

On-Brand Devices [FUJIFILM]

04547410366051This product is intended to be used in combination with FUJIFILM gastrointestinal endoscopes and
04547410366044This product is intended for use in combination with FUJIFILM 700 system scopes to deliver air a
14547410358695This device is intended for the visualization of the lower digestive tract, specifically for the
14547410358688This device is intended for the visualization of the lower digestive tract, specifically for the
14547410358671The device is intended for the visualization of the upper digestive tract, specifically for the
04547410358667The device is intended for the visualization of the upper digestive tract, specifically for the
14547410343202This device is intended for the observation, diagnosis, and endoscopic treatment of the trachea
04547410343052This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of
04547410342741The FUJIFILM ultrasonic processor SP-900 is intended to be used in combination with FUJIFILM Ult
04547410341294This device is intended for the visualization of the lower digestive tract, specifically for the
04547410341287This device is intended for the visualization of the lower digestive tract, specifically for the
04547410339437This product is the suction button used in combination with our endoscopes in medical facilities
04547410339420This product is the suction button used in combination with our endoscopes in medical facilities
04547410337730The BL-7000 Light Source is used for endoscopic observation, diagnosis, treatment, and image rec
04547410337419The VP-7000 unit is used for endoscopic observation, diagnosis, treatment, and image recording.
04547410337402The device is intended for the visualization of the upper digestive tract, specifically for the
04547410337396This device is intended for the visualization of the lower digestive tract, specifically for the
04547410334999Diathermic Slitter (FlushKnife) DK2623J is intended to be used with specified endoscopes to cut
04547410334982Diathermic Slitter (FlushKnife) DK2623J is intended to be used with specified endoscopes to cut
04547410334616Diathermic Slitter (ClutchCutter) DP2618DT is intended to be used with specified endoscopes to c
04547410334609Diathermic Slitter (ClutchCutter) DP2618DT is intended to be used with specified endoscopes to c
04547410334593Diathermic Slitter (FlushKnife) DK2623J is intended to be used with specified endoscopes to cut
04547410334586Diathermic Slitter (FlushKnife) DK2623J is intended to be used with specified endoscopes to cut
04547410334579Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
04547410334562Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
04547410334555Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
04547410334548Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
04547410334531Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
04547410334524Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
04547410334517Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
04547410334500Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
04547410334494Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut
04547410333435This product is intended to seal the acoustic coupling medium when used with Fujinon/Fujifilm ul
04547410333312This device is intended for the observation, diagnosis, and endoscopic treatment of the trachea
04547410333305This device is intended for the visualization of the lower digestive tract, specifically for the
04547410333299This device is intended for the visualization of the lower digestive tract, specifically for the
04547410332377The Fujifilm ultrasonic processors SU-1 is intended to be used in combination with Fujifilm ultr
04547410332360The Fujifilm ultrasonic processors SU-1 PLATINUM is intended to be used in combination with Fuji
04547410332353The Fujifilm ultrasonic processors SU-1 is intended to be used in combination with Fujifilm ultr
04547410332346The Fujifilm ultrasonic processors SU-1 PLATINUM is intended to be used in combination with Fuji
04547410332100This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with
04547410332094This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with
04547410332063This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with
14547410331674These hoods are intended to be used in combination with compatible endoscopes to maintain the fi
14547410331667These hoods are intended to be used in combination with compatible endoscopes to maintain the fi
14547410331650These hoods are intended to be used in combination with compatible endoscopes to maintain the fi
04547410331646The Fujifilm Double Balloon Endoscopes are intended for the visualization of the upper and lower
04547410331639This device is intended for the visualization of the upper digestive tract, specifically for the
04547410331608This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestina
04547410331592This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestina

Trademark Results [FUJIFILM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FUJIFILM
FUJIFILM
97338934 not registered Live/Pending
FUJIFILM Corporation
2022-03-30
FUJIFILM
FUJIFILM
90754468 not registered Live/Pending
FUJIFILM Corporation
2021-06-04
FUJIFILM
FUJIFILM
88939530 not registered Live/Pending
FUJIFILM Corporation
2020-05-29
FUJIFILM
FUJIFILM
88740494 not registered Live/Pending
FUJIFILM Corporation
2019-12-27
FUJIFILM
FUJIFILM
88740470 not registered Live/Pending
FUJIFILM Corporation
2019-12-27
FUJIFILM
FUJIFILM
87726002 5524338 Live/Registered
FUJIFILM Corporation
2017-12-19
FUJIFILM
FUJIFILM
87725991 not registered Dead/Abandoned
FUJIFILM Corporation
2017-12-19
FUJIFILM
FUJIFILM
85568142 4345184 Live/Registered
FUJIFILM Corporation
2012-03-13
FUJIFILM
FUJIFILM
85071890 4107458 Live/Registered
FUJIFILM Corporation
2010-06-25
FUJIFILM
FUJIFILM
79205648 5388885 Live/Registered
FUJIFILM Corporation
2016-09-02
FUJIFILM
FUJIFILM
78621281 3092797 Live/Registered
FUJIFILM CORPORATION
2005-05-02

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