HS30 Diagnostic Ultrasound System

GUDID 08806167796051

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system

• Primary Device ID: 08806167796051
• NIH Device Record Key: 9fbb088f-c5bc-4cc1-8ed7-0bec0080b5af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HS30 Diagnostic Ultrasound System
• Version Model Number: USS-HS3NL20/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	08806167796051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182632

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-10
• Device Publish Date: 2019-01-23

On-Brand Devices [HS30 Diagnostic Ultrasound System]

• 08806167796631: USS-HS3PF30/US
• 08806167796433: USS-HS3NL30/US
• 08806167796242: USS-HS3PF20/US
• 08806167796051: USS-HS3NL20/US
• 08809702988980: USS-HS3NE3B/US
• 08809702988829: USS-HS3PC3B/US
• 08809702988102: USS-HS3NL3B/US
• 08809702987914: USS-HS3PF2B/US
• 08809702987723: USS-HS3NL2B/US
• 08809702988294: USS-HS3PF3B/US