HS50 / HS60 Diagnostic Ultrasound System

GUDID 08809521027853

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system

• Primary Device ID: 08809521027853
• NIH Device Record Key: c7f7886f-6a66-444f-ad01-5fd38c79f85f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HS50 / HS60 Diagnostic Ultrasound System
• Version Model Number: USS-HS5PB4M/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	08809521027853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192505

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2020-01-20
• Device Publish Date: 2020-01-10

On-Brand Devices [HS50 / HS60 Diagnostic Ultrasound System]

• 08806167794828: USS-HS6PF4K/US
• 08806167794637: USS-HS6NL4K/US
• 08806167794453: USS-HS5PF4K/US
• 08806167794262: USS-HS5PF3K/US
• 08806167794071: USS-HS5NL4K/US
• 08806167793883: USS-HS5NL3K/US
• 08806167793333: USS-HS6PB4K/US
• 08806167793142: USS-HS6NB4K/US
• 08806167792954: USS-HS5PB4K/US
• 08806167792763: USS-HS5PB3K/US
• 08806167792572: USS-HS5NB4K/US
• 08806167792381: USS-HS5NB3K/US
• 08806167764548: USS-HS6PF40/US
• 08809521028805: USS-HS5PF3M/US
• 08809521028614: USS-HS5PB3M/US
• 08809521028423: USS-HS5NL3M/US
• 08809521028232: USS-HS5NB3M/US
• 08809521028041: USS-HS5PF4M/US
• 08809521027853: USS-HS5PB4M/US
• 08809521027662: USS-HS5NL4M/US
• 08809521027471: USS-HS5NB4M/US
• 08809521027280: USS-HS6PF4M/US
• 08809521027099: USS-HS6PB4M/US
• 08809521026900: USS-HS6NL4M/US
• 08809521026719: USS-HS6NB4M/US