Identity
- Trade Name
- Varia-NCI FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system, line-powered FDA UDI
- Device Name
- Varia-NCI accesses data from Varia TCD, a digital Transcranial Doppler (TCD) Ultrasound device. Varia-NCI is an intuitive software program that provides clinicians information on a patient’s cerebrovascular regulation by reporting key physiologic parameters, including the Neurovascular Complexity Index (NCI). Through high performance analytical processing of a TCD recording, it delivers quantitative Cerebral Blood Flow Velocity (CBFV) variability results to clinicians managing head trauma. Varia-NCI is an accessory application to the Varia TCD device. Software only device and accessory to Varia TCD. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Varia-NCI accesses data from Varia TCD, a digital Transcranial Doppler (TCD) Ultrasound device. Varia-NCI is an intuitive software program that provides clinicians information on a patient’s cerebrovascular regulation by reporting key physiologic parameters, including the Neurovascular Complexity Index (NCI). Through high performance analytical processing of a TCD recording, it delivers quantitative Cerebral Blood Flow Velocity (CBFV) variability results to clinicians managing head trauma. Varia-NCI is an accessory application to the Varia TCD device. Software only device and accessory to Varia TCD. FDA UDI
Identifiers
- Catalog Number
- 7798 FDA UDI
- Primary DI / UDI-DI
- B412779815 FDA UDI
- FDA Product Code
- IYN FDA UDI
- GMDN Term
- Noninvasive vascular ultrasound system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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Single Use
No
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Implantable
No
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Contains Latex
No
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Prescription Use
Yes
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Over-the-Counter
No
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Convenience Kit
No
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Combination Product
No
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HCT/P
No
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Premarket Exempt
No
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Lot / Batch Number
No
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Serial Number
No
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Expiration Date
No
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Manufacturing Date
No
FDA UDI
Category: Noninvasive vascular ultrasound system, line-powered
Varia-NCI by Neurochaos Solutions Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Neurochaos Solutions Inc
Sources (1)
- FDA UDI 13382fe9-4c2b-4e63-a4cf-bce59eb28543 35 fields · synced May 30, 2026