HERA W9 Diagnostic Ultrasound System

GUDID 08809725795985

HERA W9 V1.02

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system

• Primary Device ID: 08809725795985
• NIH Device Record Key: e2c62e07-847f-4950-b01e-a6a521367b3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HERA W9 Diagnostic Ultrasound System
• Version Model Number: USS-HRW9F3C/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	08809725795985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211824

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: 2021-10-18
• Device Publish Date: 2021-10-08

On-Brand Devices [HERA W9 Diagnostic Ultrasound System]

• 08809725796166: HERA W9 V1.02
• 08809725795985: HERA W9 V1.02
• 08809944938088: USS-HRW9R4E/US
• 08809944937913: USS-HRW9R3E/US
• 08809944937746: USS-HRW9F4E/US
• 08809944937555: USS-HRW9F3E/US