Primary Device ID | 04547410467710 |
NIH Device Record Key | bc6f8fee-fe50-46ad-8406-bf2d8e4429d5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FDR CROSS |
Version Model Number | DR-XD 3000 |
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 | false |
OTC Over-The-Counter | false |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
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Phone | +018002728465 |
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Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04547410467710 [Primary] |
OWB | Interventional Fluoroscopic X-Ray System |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-01-05 |
Device Publish Date | 2021-12-28 |
04547410541199 - FUJIFILM | 2024-02-26 This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as pol |
04547410509984 - FUJIFILM | 2024-01-04 This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and s |
04547410509991 - FUJIFILM | 2024-01-04 This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and s |
04547410520903 - FUJIFILM | 2023-12-25 This product is intended to be used in combination with the FUJIFILM Leak Tester LT-100 to perform leak testing for a FUJIFILM e |
14547410520917 - FUJIFILM | 2023-12-25 This product is intended to check whether the FUJIFILM Leak Tester LT-100 can properly test the airtightness of a FUJIFILM endos |
04547410377248 - FUJIFILM | 2023-12-11 FUJIFILM Endoscope Model EG-740N is intended for the visualization of the upper digestive tract, specifically for the observati |
04547410384536 - FUJIFILM | 2023-12-11 EI-580BT is a medical electronic endoscope intended to provide endoscopic images for observation, diagnosis, photographing and e |
14547410397649 - FUJIFILM | 2023-12-11 This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and end |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FDR CROSS 90602182 not registered Live/Pending |
FUJIFILM Corporation 2021-03-25 |