Primary Device ID | 04573596213667 |
NIH Device Record Key | 1d43af1e-ffe9-4a56-ba63-6ff0291fe5fc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | UST-995-7.5 |
Version Model Number | UST-995-7.5 |
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 |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 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 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 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 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 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 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 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 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 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 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 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 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 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 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 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 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 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 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 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 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 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 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 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 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 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 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 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 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 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 | 04562122956239 [Previous] |
GS1 | 04573596213667 [Primary] |
IYO | System, Imaging, Pulsed Echo, Ultrasonic |
Steralize Prior To Use | true |
Device Is Sterile | false |
[04573596213667]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide;High-level Disinfectant
[04573596213667]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide;High-level Disinfectant
[04573596213667]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide;High-level Disinfectant
[04573596213667]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide;High-level Disinfectant
[04573596213667]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide;High-level Disinfectant
[04573596213667]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide;High-level Disinfectant
[04573596213667]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide;High-level Disinfectant
[04573596213667]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide;High-level Disinfectant
[04573596213667]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide;High-level Disinfectant
[04573596213667]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide;High-level Disinfectant
[04573596213667]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide;High-level Disinfectant
[04573596213667]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide;High-level Disinfectant
[04573596213667]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide;High-level Disinfectant
[04573596213667]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide;High-level Disinfectant
[04573596213667]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide;High-level Disinfectant
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-28 |
Device Publish Date | 2025-03-20 |
04573596213216 - UST-9104-5 | 2025-03-28 Probe |
04573596213667 - UST-995-7.5 | 2025-03-28Probe |
04573596213667 - UST-995-7.5 | 2025-03-28 Probe |
04547410543858 - FUJIFILM | 2025-02-20 This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use thi |
04547410516258 - FUJIFILM | 2025-01-07 This interface cable is intended to be used for connecting the light source BL-7000X to the processor VP-7000X and for connectin |
04547410522143 - FUJIFILM | 2025-01-07 This interface cable is intended to be used for connecting the light source BL-7000X to the image processing unit EX-0. Do not u |
14547410532873 - FUJIFILM | 2024-12-30 This hood is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic proce |
04547410515893 - FUJIFILM | 2024-10-14 This product is intended to be used in combination with the compatible endoscopes, camera head, light source and light guide to |
04547410524284 - FUJIFILM | 2024-10-14 This product is intended to be used in combination with the compatible endoscopes, camera head, light source and light guide to |