RS85

GUDID 08809880020380

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system

• Primary Device ID: 08809880020380
• NIH Device Record Key: 594819e6-bc73-4bc6-a0d7-b6b1e22856ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RS85
• Version Model Number: USS-RS85F4P/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	08809880020380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221117

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: 2022-07-19
• Device Publish Date: 2022-07-11

On-Brand Devices [RS85]

• 08809880020595: USS-RS85G4P/US
• 08809880020434: USS-RS85G4I/US
• 08809880020380: USS-RS85F4P/US
• 08809880020229: USS-RS85F4I/US