VuPad Ophthalmic Ultrasound System AP.580

GUDID 00896100002019

The VuPad AP Ophthalmic Ultrasound System is a portable, ultrasound biometric ruler that is a non-invasive, active device intended for imaging ocular features for diagnostic purposes and measuring central corneal thickness. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The VuPad A-Scan is used by coupling the probe/transducer to the eye either through direct contact or by immersion method with scan mode capabilities for cataract, dense cataract, aphakic, and pseudophakic. The VuPad AP system is a stand alone system that runs on a Windows 10 platform and includes the portable A-Scan tablet, a 10 MHz A-probe, 20 MHz pachymetry probe, foot switch and operator manual.

SONOMED, INC.

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• Primary Device ID: 00896100002019
• NIH Device Record Key: 0ac412c8-58cb-4414-ba9f-0080554d63ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VuPad Ophthalmic Ultrasound System
• Version Model Number: VuPad AP
• Catalog Number: AP.580
• Company DUNS: 107037079
• Company Name: SONOMED, 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: true
• 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: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896100002019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140199

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: 2020-12-15
• Device Publish Date: 2020-12-07

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