C60xi/5-2 MHz

GUDID 00841517100384

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00841517100384
• NIH Device Record Key: 9cd90a16-b309-438d-95b3-eed1acd96360
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C60xi/5-2 MHz
• Version Model Number: P20402-10
• 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: 1-877-657-8118
• Email: ffss-service@fujifilm.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517100384 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130173

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-28
• Device Publish Date: 2016-09-13

On-Brand Devices [C60xi/5-2 MHz]

• 00841517100391: Diagnostic Ultrasound Transducer
• 00841517100384: Diagnostic Ultrasound Transducer
• 00841517105037: P20402-20
• 00841517103521: TRANSDUCER, C60XI/5-2 MHZ, ROHS, REMAN
• 00841517103378: TRANSDUCER, C60XI/5-2 MHZ, ROHS
• 00841517105068: P20402-20A
• 00841517106980: Diagnostic Ultrasound Transducer