cV8 Diagnostic Ultrasound System

GUDID 08800289970351

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system

• Primary Device ID: 08800289970351
• NIH Device Record Key: 8977434d-02c0-4fdc-8c5d-b93ceb7262c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cV8 Diagnostic Ultrasound System
• Version Model Number: cV8
• 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	08800289970351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243702

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: 2025-03-07
• Device Publish Date: 2025-02-27

Devices Manufactured by SAMSUNG MEDISON CO., LTD.

• 08800289970351 - cV8 Diagnostic Ultrasound System: 2025-03-07
• 08800289970351 - cV8 Diagnostic Ultrasound System: 2025-03-07
• 08809944884873 - BCL2-14: 2025-03-07
• 08809944967385 - cV6 Diagnostic Ultrasound System: 2025-03-07
• 08809944969341 - cV7 Diagnostic Ultrasound System: 2025-03-07
• 08809944937180 - HERA W10 Diagnostic Ultrasound System: 2024-12-16
• 08809944937371 - HERA W10 Diagnostic Ultrasound System: 2024-12-16
• 08809944937555 - HERA W9 Diagnostic Ultrasound System: 2024-12-16
• 08809944937746 - HERA W9 Diagnostic Ultrasound System: 2024-12-16