U Lite

GUDID 37011046002914

Handheld Ultrasound Scanner U Lite Pro with exchangeables probes

SONOSCANNER

General-purpose ultrasound imaging system

• Primary Device ID: 37011046002914
• NIH Device Record Key: 2712c9fd-a7bd-4620-8d76-9f3b4e9ec7a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U Lite
• Version Model Number: PRO
• Company DUNS: 267799927
• Company Name: SONOSCANNER
• 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	37011046002914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232285

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: 2024-01-24
• Device Publish Date: 2024-01-16

On-Brand Devices [U Lite ]

• 37011046002914: Handheld Ultrasound Scanner U Lite Pro with exchangeables probes
• 03701104600291: Handheld Ultrasound Scanner U Lite Pro with exchangeables probes