SonoSite Edge II

GUDID 00841517105518

Diagnostic ultrasound system

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517105518
• NIH Device Record Key: cd51fabd-0c14-4b5f-b0d9-f7329fe531a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoSite Edge II
• Version Model Number: P20680-18R
• 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(999)999-9999
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517105518 [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: 2
• Public Version Date: 2020-03-02
• Device Publish Date: 2019-11-06

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• 00841517101978: Diagnostic ultrasound system
• 00841517101817: Diagnostic ultrasound system
• 00841517101404: Diagnostic ultrasound system
• 00841517100223: Diagnostic ultrasound system
• 00841517107451: 1
• 00841517107444: 1
• 00841517107840: Diagnostic ultrasound system
• 00841517109196: P20680-45
• 00841517109165: P23610-45
• 00841517109684: Diagnostic ultrasound system
• 00841517109776: Diagnostic ultrasound device
• 00841517110147: Diagnostic ultrasound system