cV5 Diagnostic Ultrasound System

GUDID 08800289981883

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system

• Primary Device ID: 08800289981883
• NIH Device Record Key: 4e50bb80-a7ed-4282-a421-e3c9cebc4948
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cV5 Diagnostic Ultrasound System
• Version Model Number: cV5
• Company DUNS: 687785691
• Company Name: SAMSUNG MEDISON CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	08800289981883 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250999

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: 2025-09-11
• Device Publish Date: 2025-09-03

Devices Manufactured by SAMSUNG MEDISON CO., LTD.

• 08800289979132 - cV4 Diagnostic Ultrasound System: 2025-09-11 cV4 Diagnostic Ultrasound System
• 08800289981883 - cV5 Diagnostic Ultrasound System: 2025-09-11
• 08800289981883 - cV5 Diagnostic Ultrasound System: 2025-09-11
• 08806167766030 - LA3-16AD: 2025-09-11
• 08809702988614 - MMPT3-7: 2025-09-11
• 08809944884736 - TA2-9: 2025-09-11
• 08809944906476 - LM2-18D: 2025-09-11
• 08809944935292 - MMPT3-7: 2025-09-11
• 08809944942450 - miniER7: 2025-09-11