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Vave

FDA UDI

Class II (US FDA UDI)

by Vave Health Inc

Identity

Trade Name
Vave FDA UDI
Generic Name
Noninvasive vascular ultrasound system FDA UDI
Device Name
Phased Personal Ultrasound, Battery, and Battery Charger FDA UDI
Model / Reference
VUSP3, VA-0182 FDA UDI
Description
Phased Personal Ultrasound, Battery, and Battery Charger FDA UDI

Identifiers

Catalog Number
VUSP3 FDA UDI
Primary DI / UDI-DI
00850001977036 FDA UDI
510(k) Number
K191541 FDA UDI
FDA Product Code
ITX FDA UDI
IYO FDA UDI
GMDN Term
Noninvasive vascular ultrasound system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
892.1560 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

Yes

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

Yes

FDA UDI

Category: Noninvasive vascular ultrasound system

Vave by Vave Health Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Noninvasive vascular ultrasound system.

Cleared under the same submission

K191541 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vave Health Inc

Sources (1)

  • FDA UDI 376bd41d-5d4a-4879-bd85-1e856becf992 37 fields · synced May 30, 2026