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BladderScan®

FDA UDI

Class II (US FDA UDI)

by Verathon Inc.

Identity

Trade Name
BladderScan® FDA UDI
Generic Name
Ultrasound system quality assurance device FDA UDI
Model / Reference
i10™ FDA UDI

Identifiers

Catalog Number
0620-1083 FDA UDI
Primary DI / UDI-DI
00879123008145 FDA UDI
510(k) Number
K172356 FDA UDI
FDA Product Code
IYO FDA UDI
GMDN Term
Ultrasound system quality assurance device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

No

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ultrasound system quality assurance device

BladderScan® by Verathon Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasound system quality assurance device.

Cleared under the same submission

K172356 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Verathon Inc.

Sources (1)

  • FDA UDI 3e521211-8c20-4e7b-99b5-e50fb966e396 34 fields · synced Jun 8, 2026