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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
Portable/mobile rechargeable battery pack FDA UDI
Model / Reference
Battery FDA UDI

Identifiers

Catalog Number
99-02-00001 FDA UDI
Primary DI / UDI-DI
07540205000168 FDA UDI
510(k) Number
K163138 FDA UDI
K172385 FDA UDI
FDA Product Code
ITX FDA UDI
IYN FDA UDI
IYO FDA UDI
GMDN Term
Portable/mobile rechargeable battery pack 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

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: Portable/mobile rechargeable battery pack

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

Similar devices

Also classified as Portable/mobile rechargeable battery pack.

Cleared under the same submission

K163138 also covers:

K172385 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clarius Mobile Health Corp

Sources (1)

  • FDA UDI 6266ee15-83db-48a8-b468-32cab7616f65 34 fields · synced May 30, 2026