Venue Go

GUDID 00198953001097

Venue Go R6 Final Assembly

Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

General-purpose ultrasound imaging system
Primary Device ID00198953001097
NIH Device Record Keya825e539-6f3e-4c03-bf10-1455b4781c62
Commercial Distribution StatusIn Commercial Distribution
Brand NameVenue Go
Version Model NumberR6
Company DUNS119309548
Company NameGe Medical Systems, Ultrasound & Primary Care Diagnostics Llc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100198953001097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-08
Device Publish Date2025-07-31

Devices Manufactured by Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

00198953001073 - Venue2025-08-08 Venue R6 final Assembly
00198953001097 - Venue Go2025-08-08Venue Go R6 Final Assembly
00198953001097 - Venue Go2025-08-08 Venue Go R6 Final Assembly
00198953001103 - Venue Fit2025-08-08 Venue Fit R6 Final Assembly
00198953001387 - Venue Sprint2025-08-08 Venue Sprint R6 MD
00198953030233 - Caption2025-08-05 Caption AI on Vscan
00195278756138 - Invenia2025-03-20 Invenia ABUS Prime
00195278756237 - Invenia2025-03-12 Invenia ABUS Premium

Trademark Results [Venue Go]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VENUE GO
VENUE GO
87321949 5840113 Live/Registered
General Electric Company
2017-02-02

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