Power Park P12822

GUDID 00841517104641

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517104641
• NIH Device Record Key: 9ff30352-93bd-468c-abe3-366ab5855a38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Power Park
• Version Model Number: P12822-45
• Catalog Number: P12822
• 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 Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517104641 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130173

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: 2019-07-31
• Device Publish Date: 2019-07-23

On-Brand Devices [Power Park]

• 00841517104641: P12822-45
• 00841517101633: ASSEMBLY, POWERPARK STAND MODULE
• 00841517101459: P12834-40
• 00841517100094: P12834-31
• 00841517100087: P12822-31
• 00841517106348: P25003-15
• 00841517109752: Diagnostic ultrasound system
• 00841517109745: Diagnostic ultrasound system accessory
• 00841517109738: Diagnostic ultrasound system