Venue Go

GUDID 00840682138840

GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

General-purpose ultrasound imaging system

• Primary Device ID: 00840682138840
• NIH Device Record Key: bc9b5f06-8ae7-4b1e-b304-2602bc1e667c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venue Go
• Version Model Number: R2
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682138840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183362

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

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: 2019-03-11
• Device Publish Date: 2019-02-25

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