CV1-8AE

GUDID 08809725825286

SAMSUNG MEDISON CO., LTD.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 08809725825286
• NIH Device Record Key: a92e0d6b-d9d9-4738-a396-f0d3a69562fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CV1-8AE
• Version Model Number: USP-VN18FSC/WR
• Company DUNS: 687785691
• Company Name: SAMSUNG MEDISON CO., LTD.
• 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: 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	08809725825286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223387

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: 2023-02-28
• Device Publish Date: 2023-02-20

Devices Manufactured by SAMSUNG MEDISON CO., LTD.

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• 08800290041767 - EA2-11AV: 2026-02-05
• 08800290041811 - EA2-11AR: 2026-02-05
• 08800290042481 - PA2-9S: 2026-02-05
• 08800290042726 - CA2-13M: 2026-02-05
• 08800290065473 - EV2-12: 2026-02-05
• 08800289975974 - R30 Diagnostic Ultrasound System: 2026-01-28
• 08800289976025 - R20 Diagnostic Ultrasound System: 2026-01-28