HERA W10 Diagnostic Ultrasound System

GUDID 08809725796869

HERA W10 V1.02

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 08809725796869
• NIH Device Record Key: a3938144-b48b-40ef-ac68-3857a9d13cec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HERA W10 Diagnostic Ultrasound System
• Version Model Number: USS-HRW1Q4C/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	08809725796869 [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 W10 Diagnostic Ultrasound System]

• 08806167799045: USS-HRW1F40/WW
• 08806167799038: USS-HRW1F40/WR
• 08806167799137: USS-HRW1F40/US
• 08809725796869: HERA W10 V1.02
• 08809725796340: HERA W10 V1.02