UST-995-7.5

GUDID 04573596213667

Probe

FUJIFILM CORPORATION

Surgical ultrasound imaging transducer

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

Operating and Storage Conditions

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 Identifiers

Device Issuing Agency	Device ID
GS1	04562122956239 [Previous]
GS1	04573596213667 [Primary]

FDA Product Code

IYO	System, Imaging, Pulsed Echo, Ultrasonic