FC1 Ultrasound System

GUDID 00841517100940

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517100940
• NIH Device Record Key: 46039548-6a96-4c46-90bd-46a2ed1a78e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FC1 Ultrasound System
• Version Model Number: P16951-22
• 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	00841517100940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160406

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [FC1 Ultrasound System]

• 00841517103965: FC1 ULTRASOUND SYSTEM, 2.0.5
• 00841517102722: P16951-18
• 00841517102210: P16951-26
• 00841517102111: P16951-25
• 00841517100940: P16951-22
• 00841517103996: P28000-01