Clarius Ultrasound Scanner

FDA UDI

Class II (US FDA UDI)

by Clarius Mobile Health Corp

Identity

Trade Name: Clarius Ultrasound Scanner FDA UDI
Generic Name: Noninvasive device battery charger FDA UDI
Device Name: Mobile cart with multi-port battery charger FDA UDI
Model / Reference: Clarius Cart FDA UDI
Description: Mobile cart with multi-port battery charger FDA UDI

Identifiers

Catalog Number: 99-02-00039; 50-02-00033; 50-02-00039 FDA UDI
Primary DI / UDI-DI: 07540205000854 FDA UDI
510(k) Number: K180799 FDA UDI
FDA Product Code: ITX FDA UDI
IYN FDA UDI
IYO FDA UDI
GMDN Term: Noninvasive device battery charger FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
892.1550 FDA UDI
892.1560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Noninvasive device battery charger

Clarius Ultrasound Scanner by Clarius Mobile Health Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K180799 also covers:

Clarius Ultrasound Scanner — Clarius Mobile Health Corp

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: Clarius Mobile Health Corp

Sources (1)

FDA UDI fc7c46e9-b458-4434-9783-ce4f6f91f973 35 fields · synced May 31, 2026