Venue Go

FDA UDI

Class II (US FDA UDI)

by GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

Identity

Trade Name: Venue Go FDA UDI
Generic Name: General-purpose ultrasound imaging system FDA UDI
Device Name: Venue Go R3 Final Assembly FDA UDI
Model / Reference: R3 FDA UDI
Description: Venue Go R3 Final Assembly FDA UDI

Identifiers

Primary DI / UDI-DI: 00840682190503 FDA UDI
510(k) Number: K202233 FDA UDI
FDA Product Code: ITX FDA UDI
IYO FDA UDI
IYN FDA UDI
GMDN Term: General-purpose ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
892.1560 FDA UDI
892.1550 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

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

FDA UDI

Category: General-purpose ultrasound imaging system

Venue Go by GE Medical Systems Ultrasound & Primary Care Diagnostics LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K202233 also covers:

Venue GO — GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

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: GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

Sources (1)

FDA UDI 8674d5d5-9297-4d19-89f9-fda2272c870a 36 fields · synced Jun 4, 2026