VuPad Ophthalmic Ultrasound System BA.580

GUDID 00896100002132

The VuPad A/B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes both A-Scan and B-Scan capabilities. The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The A-Scan mode measures axial length (AXL), anterior chamber depth, and lens thickness and aids in the calculation of associated IOL power for implanted lenses. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable A/B-scan tablet, 12 MHz B-probe, 10 MHz A-probe, built-in probe holders, foot switch and user manual.

SONOMED, INC.

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• Primary Device ID: 00896100002132
• NIH Device Record Key: da7227ad-f23d-41b9-862d-c30b48ac22ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VuPad Ophthalmic Ultrasound System
• Version Model Number: VuPad A/B
• Catalog Number: BA.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	00896100002132 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-06-23
• Device Publish Date: 2016-08-10

On-Brand Devices [VuPad Ophthalmic Ultrasound System]

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• 00896100002163: The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric devic
• 00896100002156: The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric devic
• 00896100002149: The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic, ultrasound biomicr
• 00896100002132: The VuPad A/B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biomet
• 00896100002125: The VuPad B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometri
• 00896100002064: The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric devic
• 00896100002057: The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric devic
• 00896100002040: The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic, ultrasound biomicr
• 00896100002033: The VuPad A/B/P Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric
• 00896100002026: The VuPad BP Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric de
• 00896100002019: The VuPad AP Ophthalmic Ultrasound System is a portable, ultrasound biometric ruler that is a no