NovaKit Exam Pack (NovaKit) NA-DSP2

GUDID 10850681007198

The NovaKit contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots.

Novasignal Corp.

Noninvasive vascular ultrasound support kit

• Primary Device ID: 10850681007198
• NIH Device Record Key: 3296fc09-e056-4af4-b34b-cf7ed6359aca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovaKit Exam Pack (NovaKit)
• Version Model Number: NA-DSP2
• Catalog Number: NA-DSP2
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00850681007191 [Primary]
GS1	10850681007198 [Package]; Contains: 00850681007191; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180455

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: 2020-09-08
• Device Publish Date: 2020-08-31

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
• 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): 2020-09-08The NovaKit contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots.
• 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.