SonoSite LX

GUDID 00841517107543

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517107543
• NIH Device Record Key: c5028c0c-bd72-43a7-ab18-c6e3346ea580
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoSite LX
• Version Model Number: P28354-25
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517107543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213763

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-16
• Device Publish Date: 2022-02-08

On-Brand Devices [SonoSite LX]

• 00841517107543: P28354-25
• 00841517107574: P30571-01
• 00841517107666: P28354-30
• 00841517109905: Diagnostic Ultrasound System
• 00841517110093: Diagnostic ultrasound transducer
• 00841517110031: Diagnostic Ultrasound system
• 00841517110024: Diagnostic ultrasound system accessory
• 00841517110185: Diagnostic ultrasound system
• 00841517110765: Diagnostic ultrasound system
• 00841517110826: Diagnostic Ultrasound System
• 00841517111878: SONOSITE LX ULTRASOUND SYSTEM, 4.2