BCL2-14

GUDID 08809944884873

SAMSUNG MEDISON CO., LTD.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 08809944884873
• NIH Device Record Key: 26645384-b07f-474f-8a69-03b6a8304043
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BCL2-14
• Version Model Number: USP-B02EF1A/WR
• 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	08809944884873 [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
• 08809944884873 - BCL2-14: 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