Venue Sprint

GUDID 00198953001387

Venue Sprint R6 MD

Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

Ultrasound imaging system application software
Primary Device ID00198953001387
NIH Device Record Keya1d9073c-7233-4372-8601-c13066d088fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameVenue Sprint
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100198953001387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, 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 Go2025-08-08 Venue Go R6 Final Assembly
00198953001103 - Venue Fit2025-08-08 Venue Fit R6 Final Assembly
00198953001387 - Venue Sprint2025-08-08Venue Sprint R6 MD
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 Sprint]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VENUE SPRINT
VENUE SPRINT
98095519 not registered Live/Pending
GE HealthCare Medical Technology LLC
2023-07-21

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