EUP-F531

GUDID 04573596211687

Probe

FUJIFILM HEALTHCARE CORPORATION

Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer
Primary Device ID04573596211687
NIH Device Record Key862bd1f6-72ae-4113-9158-8b9e0cc0577c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEUP-F531
Version Model NumberEUP-F531
Company DUNS718262719
Company NameFUJIFILM HEALTHCARE CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 25 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104573596211687 [Primary]
GS104580292773470 [Previous]

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04573596211687]

Hydrogen Peroxide;Ethylene Oxide


[04573596211687]

Hydrogen Peroxide;Ethylene Oxide


[04573596211687]

Hydrogen Peroxide;Ethylene Oxide


[04573596211687]

Hydrogen Peroxide;Ethylene Oxide


[04573596211687]

Hydrogen Peroxide;Ethylene Oxide


[04573596211687]

Hydrogen Peroxide;Ethylene Oxide


[04573596211687]

Hydrogen Peroxide;Ethylene Oxide


[04573596211687]

Hydrogen Peroxide;Ethylene Oxide


[04573596211687]

Hydrogen Peroxide;Ethylene Oxide


[04573596211687]

Hydrogen Peroxide;Ethylene Oxide


[04573596211687]

Hydrogen Peroxide;Ethylene Oxide


[04573596211687]

Hydrogen Peroxide;Ethylene Oxide


[04573596211687]

Hydrogen Peroxide;Ethylene Oxide


[04573596211687]

Hydrogen Peroxide;Ethylene Oxide


[04573596211687]

Hydrogen Peroxide;Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-26
Device Publish Date2021-07-18

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