NovaGuide™ Intelligent Ultrasound System NA-RBTSYS1

GUDID 00850681007443

Novasignal Corp.

Noninvasive vascular ultrasound system, line-powered

• Primary Device ID: 00850681007443
• NIH Device Record Key: 21f5cf98-8f2d-4d47-87cb-1a7b77655673
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovaGuide™ Intelligent Ultrasound System
• Version Model Number: 05-00019
• Catalog Number: NA-RBTSYS1
• Company DUNS: 078766464
• Company Name: Novasignal Corp.
• 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	00850681007443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180455

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, 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: 2022-08-29
• Device Publish Date: 2022-08-19

Devices Manufactured by Novasignal Corp.

• 00850681007351 - NovaKit™ 2 Exam Pack: 2022-08-29
• 00850681007399 - NovaGuide™ 2 Intelligent Ultrasound System: 2022-08-29
• 00850681007405 - NovaGuide™ 2 Traditional Ultrasound System: 2022-08-29
• 00850681007443 - NovaGuide™ Intelligent Ultrasound System: 2022-08-29
• 00850681007443 - NovaGuide™ Intelligent Ultrasound System: 2022-08-29
• 00850681007184 - NovaBot Automated Headset: 2020-09-08 NovaBot Automated Headset accessory for the Lucid TCD. When connected to the Lucid TCD, the combined device is referred to as th
• 10850681007198 - NovaKit Exam Pack (NovaKit): 2020-09-08 The NovaKit contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padd
• 00850681007221 - Lucid Transcranial Doppler Ultrasound System (Lucid TCD): 2020-09-08 The Lucid TCD is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuring and
• 10850681007174 - Temporal Monitoring Headframe Foam Procedural Set, Packaged 10-Pack: 2020-08-03 A box of 10 procedural sets that include replacement foam for the Neural Analytics Temporal Monitoring Headframe.