Venue

GUDID 00840682138888

GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

General-purpose ultrasound imaging system

• Primary Device ID: 00840682138888
• NIH Device Record Key: 85f60462-5d8a-4b2a-bc13-45c9d3a50af3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venue
• 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 Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682138888 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180599

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: 2018-07-09
• Device Publish Date: 2018-06-08

On-Brand Devices [Venue]

• 00840682139212: R2 UPG
• 00840682138888: R2
• 00840682123815: R1
• 00840682190510: Venue R3 final Assembly
• 00195278005830: Venue R3 MD eDelivery or Physical Upgrade
• 00195278516534: Venue R4 MD either eDelivery or physical
• 00195278516480: Venue R4 final Assembly
• 00195278703477: Venue R5 MD
• 00195278703200: Venue R5 final Assembly