L38xp/10-5 MHz P14565

GUDID 00841517111755

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00841517111755
• NIH Device Record Key: ba2c3024-f0ba-4853-947f-52e6111d8df5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L38xp/10-5 MHz
• Version Model Number: P14565-22A
• Catalog Number: P14565
• Company DUNS: 014438860
• Company Name: FUJIFILM SONOSITE, INC.
• 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 Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 65 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 65 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517111755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171437

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-08
• Device Publish Date: 2025-04-30

On-Brand Devices [L38xp/10-5 MHz]

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• 00841517103323: Diagnostic Ultrasound Transducer
• 00841517101114: Diagnostic Ultrasound Transducer
• 00841517101107: Diagnostic Ultrasound Transducer
• 00841517107031: Diagnostic Ultrasound Transducer
• 00841517109493: Diagnostic ultrasound transducer
• 00841517111755: Diagnostic Ultrasound Transducer