Venue GO

GUDID 00195278005861

Venue Go R3 MD eDelivery or Physical Upgrade

GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

General-purpose ultrasound imaging system

• Primary Device ID: 00195278005861
• NIH Device Record Key: 4ca613ef-7449-4b13-8998-9e6fe7dd1903
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venue GO
• Version Model Number: R3 UPG
• Company DUNS: 078863378
• Company Name: GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278005861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202233

FDA Product Code

• IYN: System, imaging, pulsed doppler, ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-02
• Device Publish Date: 2020-11-24

Devices Manufactured by GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

• 00195278687777 - Venue Go: 2024-07-18 Venue Go R5 MD
• 00195278703200 - Venue: 2024-07-18 Venue R5 final Assembly
• 00195278703224 - Venue Fit: 2024-07-18 Venue Fit R5 Final Assembly
• 00195278703453 - Venue Go: 2024-07-18 Venue Go R5 Final Assembly
• 00195278703477 - Venue: 2024-07-18 Venue R5 MD
• 00195278703484 - Venue Fit: 2024-07-18 Venue Fit R5 MD
• 00195278754011 - Venue Sprint: 2024-07-18 Venue Sprint R5 MD
• 00195278680938 - LOGIQ: 2023-12-12 LOGIQ E10 R4 Console