L25x/13-6 MHz

GUDID 00841517100438

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00841517100438
• NIH Device Record Key: aaef6d1d-be50-4fec-865f-91b9dedc95a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L25x/13-6 MHz
• Version Model Number: P07691-70
• 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	00841517100438 [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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-13

On-Brand Devices [L25x/13-6 MHz]

• 00841517105006: Diagnostic Ultrasound Transducer
• 00841517104863: Diagnostic Ultrasound Transducer
• 00841517104856: Diagnostic Ultrasound Transducer
• 00841517102906: Diagnostic Ultrasound Transducer
• 00841517102258: Diagnostic Ultrasound Transducer
• 00841517102241: Diagnostic Ultrasound Transducer
• 00841517100445: Diagnostic Ultrasound Transducer
• 00841517100438: Diagnostic Ultrasound Transducer
• 00841517106942: Diagnostic Ultrasound Transducer
• 00841517107581: P22950-20A
• 00841517107932: Diagnostic Ultrasound Transducer
• 00841517109110: Diagnostic Ultrasound Transducer
• 00841517108946: Diagnostic Ultrasound Transducer