Venue Sprint

GUDID 00195278754011

Venue Sprint R5 MD

GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

Ultrasound imaging system application software

• Primary Device ID: 00195278754011
• NIH Device Record Key: d743ff68-8086-47b2-895d-21495cd7403e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venue Sprint
• Version Model Number: R5
• 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	00195278754011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240206

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

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

• 00840682147118 - LOGIQ: 2025-10-01 LOGIQ E10 R1 to R2 UPG
• 00195278869616 - LOGIQ: 2024-12-16 LOGIQ E10-V R4 Console
• 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