HERA Z20

GUDID 08809944906872

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system

• Primary Device ID: 08809944906872
• NIH Device Record Key: a46de03d-c2ba-484b-aaab-db45e6f22b05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HERA Z20
• Version Model Number: USS-HZ2N0F04/US
• 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	08809944906872 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241971

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: 2024-10-24
• Device Publish Date: 2024-10-16

Devices Manufactured by SAMSUNG MEDISON CO., LTD.

• 08809944906377 - CMV1-10Z: 2024-10-24
• 08809944906438 - CMV1-10: 2024-10-24
• 08809944906872 - HERA Z20: 2024-10-24
• 08809944906872 - HERA Z20: 2024-10-24
• 08809944935018 - SonoSync: 2024-09-05
• 08809944884750 - TA2-9: 2024-07-04
• 08809944885757 - RS85 Diagnostic Ultrasound System: 2024-06-25
• 08809944885801 - RS85 Diagnostic Ultrasound System: 2024-06-25
• 08809944885979 - RS85 Diagnostic Ultrasound System: 2024-06-25