SonoSite iViz P20830

GUDID 00841517101855

Diagnostic ultrasound system

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517101855
• NIH Device Record Key: b4de1b24-e515-4c73-8673-70c978775ad4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoSite iViz
• Version Model Number: P20830-20
• Catalog Number: P20830
• 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: xyz@xyz.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517101855 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161119

FDA Product Code

• IYN: System, imaging, pulsed doppler, ultrasonic

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: 2017-02-20

On-Brand Devices [SonoSite iViz]

• 00841517104566: Diagnostic ultrasound system
• 00841517103842: Diagnostic ultrasound system
• 00841517103835: Diagnostic ultrasound system
• 00841517103712: Diagnostic ultrasound system
• 00841517102203: Diagnostic ultrasound system
• 00841517101862: Diagnostic ultrasound system
• 00841517101855: Diagnostic ultrasound system
• 00841517101671: Diagnostic ultrasound system
• 00841517101572: Diagnostic ultrasound system
• 00841517101442: Diagnostic ultrasound system
• 00841517101206: Diagnostic ultrasound system
• 00841517100896: Diagnostic ultrasound system
• 00841517104719: P20830-26
• 00841517104313: Diagnostic ultrasound system
• 00841517107468: 1