Venue Fit

GUDID 00198953001424

Venue Fit R6 MD

Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

General-purpose ultrasound imaging system

• Primary Device ID: 00198953001424
• NIH Device Record Key: 99f3cf12-3a87-4925-80d4-f2b1d56b93b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venue Fit
• Version Model Number: R6 UPG
• 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	00198953001424 [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: 2025-11-25
• Device Publish Date: 2025-11-17

On-Brand Devices [Venue Fit]

• 00198953001103: Venue Fit R6 Final Assembly
• 00198953001424: Venue Fit R6 MD