Power Pack P13559

GUDID 00841517105594

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517105594
• NIH Device Record Key: f5ee8d54-930d-4208-8535-883975163535
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Power Pack
• Version Model Number: P13559-06
• Catalog Number: P13559
• 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

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517105594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102390

FDA Product Code

• IYO: System, imaging, pulsed echo, ultrasonic

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: 2019-12-18
• Device Publish Date: 2019-12-10

On-Brand Devices [Power Pack]

• 00841517105594: P13559-06
• 00841517100681: P13559-05
• 00841517100100: P13122-02