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 ID | 14547410500643 |
| NIH Device Record Key | 1b0cd9ba-33a8-427f-bb19-dfdbe3c4f0de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FUJIFILM |
| Version Model Number | EG-840N |
| Company DUNS | 713565195 |
| Company Name | FUJIFILM CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *no dew condensation |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *no dew condensation |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *no dew condensation |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *no dew condensation |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *no dew condensation |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *no dew condensation |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *no dew condensation |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *no dew condensation |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *no dew condensation |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *no dew condensation |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *no dew condensation |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *no dew condensation |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *no dew condensation |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *no dew condensation |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *no dew condensation |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *no dew condensation |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *no dew condensation |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04547410500646 [Primary] |
| GS1 | 14547410500643 [Package] Contains: 04547410500646 Package: Box [1 Units] In Commercial Distribution |
FDA Product Code
| FDS | Gastroscope And Accessories, Flexible/Rigid |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[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 Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-30 |
| Device Publish Date | 2024-09-20 |
On-Brand Devices [FUJIFILM]
| 04547410366051 | This product is intended to be used in combination with FUJIFILM gastrointestinal endoscopes and |
| 04547410366044 | This product is intended for use in combination with FUJIFILM 700 system scopes to deliver air a |
| 14547410358695 | This device is intended for the visualization of the lower digestive tract, specifically for the |
| 14547410358688 | This device is intended for the visualization of the lower digestive tract, specifically for the |
| 14547410358671 | The device is intended for the visualization of the upper digestive tract, specifically for the |
| 04547410358667 | The device is intended for the visualization of the upper digestive tract, specifically for the |
| 14547410343202 | This device is intended for the observation, diagnosis, and endoscopic treatment of the trachea |
| 04547410343052 | This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of |
| 04547410342741 | The FUJIFILM ultrasonic processor SP-900 is intended to be used in combination with FUJIFILM Ult |
| 04547410341294 | This device is intended for the visualization of the lower digestive tract, specifically for the |
| 04547410341287 | This device is intended for the visualization of the lower digestive tract, specifically for the |
| 04547410339437 | This product is the suction button used in combination with our endoscopes in medical facilities |
| 04547410339420 | This product is the suction button used in combination with our endoscopes in medical facilities |
| 04547410337730 | The BL-7000 Light Source is used for endoscopic observation, diagnosis, treatment, and image rec |
| 04547410337419 | The VP-7000 unit is used for endoscopic observation, diagnosis, treatment, and image recording. |
| 04547410337402 | The device is intended for the visualization of the upper digestive tract, specifically for the |
| 04547410337396 | This device is intended for the visualization of the lower digestive tract, specifically for the |
| 04547410334999 | Diathermic Slitter (FlushKnife) DK2623J is intended to be used with specified endoscopes to cut |
| 04547410334982 | Diathermic Slitter (FlushKnife) DK2623J is intended to be used with specified endoscopes to cut |
| 04547410334616 | Diathermic Slitter (ClutchCutter) DP2618DT is intended to be used with specified endoscopes to c |
| 04547410334609 | Diathermic Slitter (ClutchCutter) DP2618DT is intended to be used with specified endoscopes to c |
| 04547410334593 | Diathermic Slitter (FlushKnife) DK2623J is intended to be used with specified endoscopes to cut |
| 04547410334586 | Diathermic Slitter (FlushKnife) DK2623J is intended to be used with specified endoscopes to cut |
| 04547410334579 | Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut |
| 04547410334562 | Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut |
| 04547410334555 | Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut |
| 04547410334548 | Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut |
| 04547410334531 | Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut |
| 04547410334524 | Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut |
| 04547410334517 | Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut |
| 04547410334500 | Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut |
| 04547410334494 | Diathermic Slitter (FlushKnife) DK2618J is intended to be used with specified endoscopes to cut |
| 04547410333435 | This product is intended to seal the acoustic coupling medium when used with Fujinon/Fujifilm ul |
| 04547410333312 | This device is intended for the observation, diagnosis, and endoscopic treatment of the trachea |
| 04547410333305 | This device is intended for the visualization of the lower digestive tract, specifically for the |
| 04547410333299 | This device is intended for the visualization of the lower digestive tract, specifically for the |
| 04547410332377 | The Fujifilm ultrasonic processors SU-1 is intended to be used in combination with Fujifilm ultr |
| 04547410332360 | The Fujifilm ultrasonic processors SU-1 PLATINUM is intended to be used in combination with Fuji |
| 04547410332353 | The Fujifilm ultrasonic processors SU-1 is intended to be used in combination with Fujifilm ultr |
| 04547410332346 | The Fujifilm ultrasonic processors SU-1 PLATINUM is intended to be used in combination with Fuji |
| 04547410332100 | This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with |
| 04547410332094 | This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with |
| 04547410332063 | This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with |
| 14547410331674 | These hoods are intended to be used in combination with compatible endoscopes to maintain the fi |
| 14547410331667 | These hoods are intended to be used in combination with compatible endoscopes to maintain the fi |
| 14547410331650 | These hoods are intended to be used in combination with compatible endoscopes to maintain the fi |
| 04547410331646 | The Fujifilm Double Balloon Endoscopes are intended for the visualization of the upper and lower |
| 04547410331639 | This device is intended for the visualization of the upper digestive tract, specifically for the |
| 04547410331608 | This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestina |
| 04547410331592 | This 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 97338934 not registered Live/Pending |
FUJIFILM Corporation 2022-03-30 |
 FUJIFILM 90754468 not registered Live/Pending |
FUJIFILM Corporation 2021-06-04 |
 FUJIFILM 88939530 not registered Live/Pending |
FUJIFILM Corporation 2020-05-29 |
 FUJIFILM 88740494 not registered Live/Pending |
FUJIFILM Corporation 2019-12-27 |
 FUJIFILM 88740470 not registered Live/Pending |
FUJIFILM Corporation 2019-12-27 |
 FUJIFILM 87726002 5524338 Live/Registered |
FUJIFILM Corporation 2017-12-19 |
 FUJIFILM 87725991 not registered Dead/Abandoned |
FUJIFILM Corporation 2017-12-19 |
 FUJIFILM 85568142 4345184 Live/Registered |
FUJIFILM Corporation 2012-03-13 |
 FUJIFILM 85071890 4107458 Live/Registered |
FUJIFILM Corporation 2010-06-25 |
 FUJIFILM 79205648 5388885 Live/Registered |
FUJIFILM Corporation 2016-09-02 |
 FUJIFILM 78621281 3092797 Live/Registered |
FUJIFILM CORPORATION 2005-05-02 |
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