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Varia TCD

FDA UDI

Class II (US FDA UDI)

by Neurochaos Solutions Inc

Identity

Trade Name
Varia TCD FDA UDI
Generic Name
Noninvasive vascular ultrasound system, line-powered FDA UDI
Device Name
The Varia Transcranial Doppler Ultrasound (TCD) device provides precision measurements of cerebrovascular blood flow. Designed to exacting standards, Varia delivers excellent signal quality with minimal ambient noise, allowing clinicians to easily locate vessels and obtain high-quality measurements. When attached to an external MS Windows-based computer, Varia presents the clinician with an intuitive interface including clear displays and easy-to-use input parameters to facilitate a quality exam. Utilized with software only device accessory Varia-NCI. FDA UDI
Model / Reference
1 FDA UDI
Description
The Varia Transcranial Doppler Ultrasound (TCD) device provides precision measurements of cerebrovascular blood flow. Designed to exacting standards, Varia delivers excellent signal quality with minimal ambient noise, allowing clinicians to easily locate vessels and obtain high-quality measurements. When attached to an external MS Windows-based computer, Varia presents the clinician with an intuitive interface including clear displays and easy-to-use input parameters to facilitate a quality exam. Utilized with software only device accessory Varia-NCI. FDA UDI

Identifiers

Catalog Number
7800 FDA UDI
Primary DI / UDI-DI
B41278000 FDA UDI
FDA Product Code
ITX FDA UDI
IYN FDA UDI
GMDN Term
Noninvasive vascular ultrasound system, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
892.1550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Invasive vascular ultrasound systemNoninvasive vascular ultrasound system, line-powered

Varia TCD by Neurochaos Solutions Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Noninvasive vascular ultrasound system, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neurochaos Solutions Inc

Sources (1)

  • FDA UDI 62bbefff-e172-4643-836e-017d4228e512 35 fields · synced May 30, 2026