McKesson

FDA UDI

Class II (US FDA UDI)

by Mckesson Medical-Surgical Inc.

Identity

Trade Name: McKesson FDA UDI
Generic Name: Bladder volume ultrasound imaging system FDA UDI
Device Name: SCANNER, BLADDER PORTABLE ULTRASOUND FDA UDI
Model / Reference: 259-M2 FDA UDI
Description: SCANNER, BLADDER PORTABLE ULTRASOUND FDA UDI

Identifiers

Primary DI / UDI-DI: 10612479274669 FDA UDI
510(k) Number: K190769 FDA UDI
FDA Product Code: IYO FDA UDI
GMDN Term: Bladder volume ultrasound imaging system 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

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bladder volume ultrasound imaging system

McKesson by Mckesson Medical-Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bladder volume ultrasound imaging system.

BladderScan® — Verathon Inc. · Class II
BladderScan® — Verathon Inc. · Class II
Bladder Scanner — Suzhou PeakSonic Medical Technology Co., LTD. · Class II
BBS Revolution™ — Dbmedx, Inc. · Class II
Caresono — Caresono Technology Co., Ltd. · Class II
AVANTSONIC — Avantsonic Technology Co., Ltd. · Class II
Bladder Scanner — Suzhou PeakSonic Medical Technology Co., LTD. · Class II
ScanPoint® — Verathon Inc. · Class II

Cleared under the same submission

K190769 also covers:

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: Mckesson Medical-Surgical Inc.

Sources (1)

FDA UDI 8a524a90-d2d9-4378-9234-36c91fc04927 34 fields · synced Jun 8, 2026