Venue Sprint

GUDID 00198953001387

Venue Sprint R6 MD

Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

Ultrasound imaging system application software

• Primary Device ID: 00198953001387
• NIH Device Record Key: a1d9073c-7233-4372-8601-c13066d088fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venue Sprint
• Version Model Number: R6
• Company DUNS: 119309548
• 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	00198953001387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251322

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: 2025-08-08
• Device Publish Date: 2025-07-31

Devices Manufactured by Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

• 00195278942241 - LOGIQ: 2025-12-15 LOGIQ E10 R2R3 to R4 UPG
• 00198953042748 - LOGIQ: 2025-12-15 LOGIQ E10 R4_R5 UPG
• 00198953042816 - LOGIQ: 2025-12-15 LOGIQ E10 R5 Console
• 00198953001400 - Venue: 2025-11-25 Venue R6 MD
• 00198953001424 - Venue Fit: 2025-11-25 Venue Fit R6 MD
• 00198953001431 - Venue Go: 2025-11-25 Venue Go R6 MD
• 00198953038604 - Caption: 2025-09-23 Caption Cardiac Guidance on Venue
• 00198953001073 - Venue: 2025-08-08 Venue R6 final Assembly