EUP-O54J

GUDID 04573596211830

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 ID: 04573596211830
• NIH Device Record Key: 6d594d73-d40f-456a-a338-24c7e47ce6ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EUP-O54J
• Version Model Number: EUP-O54J
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04573596211830 [Primary]
GS1	04580292773784 [Previous]

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04573596211830]

Hydrogen Peroxide;Ethylene Oxide

[04573596211830]

Hydrogen Peroxide;Ethylene Oxide

[04573596211830]

Hydrogen Peroxide;Ethylene Oxide

[04573596211830]

Hydrogen Peroxide;Ethylene Oxide

[04573596211830]

Hydrogen Peroxide;Ethylene Oxide

[04573596211830]

Hydrogen Peroxide;Ethylene Oxide

[04573596211830]

Hydrogen Peroxide;Ethylene Oxide

[04573596211830]

Hydrogen Peroxide;Ethylene Oxide

[04573596211830]

Hydrogen Peroxide;Ethylene Oxide

[04573596211830]

Hydrogen Peroxide;Ethylene Oxide

[04573596211830]

Hydrogen Peroxide;Ethylene Oxide

[04573596211830]

Hydrogen Peroxide;Ethylene Oxide

[04573596211830]

Hydrogen Peroxide;Ethylene Oxide

[04573596211830]

Hydrogen Peroxide;Ethylene Oxide

[04573596211830]

Hydrogen Peroxide;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-26
• Device Publish Date: 2021-07-18

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