HERA W9, HERA W10 Diagnostic Ultrasound System

GUDID 08809880044485

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system

• Primary Device ID: 08809880044485
• NIH Device Record Key: 3fa0df8d-0a95-486a-b2f4-e8ac95dcacf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HERA W9, HERA W10 Diagnostic Ultrasound System
• Version Model Number: USS-HW1ER4D/US
• 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	08809880044485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230084

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: 2023-05-03
• Device Publish Date: 2023-04-25

On-Brand Devices [HERA W9, HERA W10 Diagnostic Ultrasound System]

• 08809880049220: USS-HRW9R3D/US
• 08809880049084: USS-HRW9R4D/US
• 08809880044485: USS-HW1ER4D/US
• 08809880033519: USS-HRW9F3D/US
• 08809880033274: USS-HRW9F4D/US
• 08809880032949: USS-HRW1F4D/US
• 08809880032734: USS-HRW1R4D/US