Primary Device ID | 04573596212110 |
NIH Device Record Key | 6e1cf96e-6e54-439f-a7c9-8069078c24d7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | L46K |
Version Model Number | L46K |
Company DUNS | 718262719 |
Company Name | FUJIFILM HEALTHCARE 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 |
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 |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04562122958257 [Previous] |
GS1 | 04573596212110 [Primary] |
IYO | System, Imaging, Pulsed Echo, Ultrasonic |
Steralize Prior To Use | true |
Device Is Sterile | false |
[04573596212110]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide
[04573596212110]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide
[04573596212110]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide
[04573596212110]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide
[04573596212110]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide
[04573596212110]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide
[04573596212110]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide
[04573596212110]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide
[04573596212110]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide
[04573596212110]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide
[04573596212110]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide
[04573596212110]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide
[04573596212110]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide
[04573596212110]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide
[04573596212110]
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-07-26 |
Device Publish Date | 2021-07-18 |
04573596204382 - FUJIFILM | 2024-07-22 |
04573596212011 - L31KP | 2024-02-02 Probe |
04573596212318 - S3ESCLS | 2024-02-02 Probe |
04573596212035 - L35 | 2024-01-30 Probe |
04573596212455 - UST-2266-5 | 2024-01-30 Probe |
04573596214176 - CL4416R1 | 2024-01-30 Probe |
04573596214336 - C421 | 2024-01-30 Probe |
04573596214503 - CC41R2 | 2024-01-30 Probe |