UHF48 Transducer 51415

GUDID 00841517104528

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517104528
• NIH Device Record Key: 39b88958-3877-49a4-b809-297d9ea31712
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UHF48 Transducer
• Version Model Number: 51415-50
• Catalog Number: 51415
• 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

Customer Support Contacts

• Phone: +1(999)999-9999
• Email: xx@xx.xx

Operating and Storage Conditions

• Handling Environment Temperature: Between -35 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517104528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160674

FDA Product Code

• IYN: System, imaging, pulsed doppler, ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-02
• Device Publish Date: 2019-01-23

On-Brand Devices [UHF48 Transducer]

• 00841517104689: Diagnostic Ultrasound Transducer
• 00841517104528: Diagnostic Ultrasound Transducer
• 00841517102333: Diagnostic Ultrasound Transducer
• 00841517102326: Diagnostic Ultrasound Transducer
• 00841517100728: Diagnostic Ultrasound Transducer
• 00841517100711: Diagnostic Ultrasound Transducer