C35x/8-3 MHz

GUDID 00841517100674

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00841517100674
• NIH Device Record Key: 07dcaca0-e25d-4477-9fb2-908fe2ab29d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C35x/8-3 MHz
• Version Model Number: P21981-10
• 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 Temperature: Between -35 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517100674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153626

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 [C35x/8-3 MHz]

• 00841517105013: P21981-20A
• 00841517104986: P21981-20
• 00841517100674: Diagnostic Ultrasound Transducer
• 00841517101480: P21981-10A
• 00841517109103: DIAGNOSTIC ULTRAOSUND TRANSDUCER