Venue Go

GUDID 00195278687777

Venue Go R5 MD

GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

General-purpose ultrasound imaging system

• Primary Device ID: 00195278687777
• NIH Device Record Key: dc496b45-90f4-48da-97dc-563d8416a635
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venue Go
• Version Model Number: R5 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: Labeling does not contain MRI Safety Information
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278687777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240053

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: 2024-07-18
• Device Publish Date: 2024-07-10

On-Brand Devices [Venue Go]

• 00840682138840: R2
• 00840682190503: Venue Go R3 Final Assembly
• 00195278516541: Venue Go R4 MD either eDelivery or physical
• 00195278516510: Venue Go R4 Final Assembly
• 00195278703453: Venue Go R5 Final Assembly
• 00195278687777: Venue Go R5 MD