Sonosite PX

GUDID 00841517105952

FUJIFILM SONOSITE, INC.

Rechargeable battery pack

• Primary Device ID: 00841517105952
• NIH Device Record Key: 1e555c19-d26f-4077-a13a-60b1e611bbfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonosite PX
• Version Model Number: P23597-03
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517105952 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200964

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2021-12-22
• Device Publish Date: 2021-12-13

On-Brand Devices [Sonosite PX ]

• 00841517105952: P23597-03
• 00841517107659: P25000-30
• 00841517109899: Diagnostic Ultrasound System
• 00841517109950: Diagnostic ultrasound loaner system
• 00841517109943: Diagnostic ultrasound system
• 00841517110178: SONOSITE PX ULTRASOUND SYSTEM, 3.1.1, UKCA
• 00841517110758: Diagnostic ultrasound system