HS40

GUDID 08809880021929

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system

• Primary Device ID: 08809880021929
• NIH Device Record Key: bf050b24-b19c-474d-bd91-691efd52f0b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HS40
• Version Model Number: USS-HS4PF3F/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	08809880021929 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221599

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: 2022-09-02
• Device Publish Date: 2022-08-25

On-Brand Devices [HS40]

• 08809725785962: USS-HS4NB3E/US
• 08809725787027: USS-HS4NF3E/US
• 08809725785740: USS-HS4NF4E/US
• 08809725785221: USS-HS4NL4E/US
• 08809725785023: USS-HS4NB4E/US
• 08809880022933: USS-HS4PB4F/US
• 08809880022766: USS-HS4PB3F/US
• 08809880022605: USS-HS4NG4F/US
• 08809880022438: USS-HS4NG3F/US
• 08809880022261: USS-HS4NB4F/US
• 08809880022094: USS-HS4PF4F/US
• 08809880021929: USS-HS4PF3F/US
• 08809880021745: USS-HS4NL4F/US
• 08809880021578: USS-HS4NL3F/US
• 08809880021400: USS-HS4NF4F/US
• 08809880021233: USS-HS4NF3F/US
• 08809880021066: USS-HS4NB3F/US