Edge Mini-Dock

GUDID 00841517100117

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517100117
• NIH Device Record Key: 122a869f-11dd-4264-b892-a52f30ca7b8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edge Mini-Dock
• Version Model Number: P15078-41
• 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 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517100117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133454

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: 2016-09-12

On-Brand Devices [Edge Mini-Dock]

• 00841517100117: P15078-41
• 00841517107598: P15078-16
• 00841517108113: MINIDOCK, DESKTOP VERSION
• 00841517108373: Edge Accessory
• 00841517110369: DIAGNOSTIC ULTRASOUND ACCAESSORY