HS70A Diagnostic Ultrasound System

GUDID 08809702982940

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system

• Primary Device ID: 08809702982940
• NIH Device Record Key: 35b2834f-d713-4e4c-a375-c0b5e52d9e1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HS70A Diagnostic Ultrasound System
• Version Model Number: USS-HS7AL4M/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	08809702982940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200699

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: 2020-09-07
• Device Publish Date: 2020-08-28

On-Brand Devices [HS70A Diagnostic Ultrasound System]

• 08806167789220: USS-HS7AL4L/WW
• 08809702982797: USS-HS7AL3M/US
• 08809702982629: USS-HS7AF4M/US
• 08809702982469: USS-HS7AF3M/US
• 08809702982940: USS-HS7AL4M/US
• 08809725781940: USS-HS7NF4N/US
• 08809725781797: USS-HS7NF3N/US
• 08809725780370: USS-HS7AL4N/US
• 08809725780202: USS-HS7AL3N/US
• 08809725780035: USS-HS7AF4N/US
• 08809702989864: USS-HS7AF3N/US