RS85 Diagnostic Ultrasound System

GUDID 08809944885979

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 08809944885979
• NIH Device Record Key: e27229f0-0d0f-497f-9854-be2e7418600a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RS85 Diagnostic Ultrasound System
• Version Model Number: USS-RS85E4S/US
• Company DUNS: 687785691
• Company Name: SAMSUNG MEDISON CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	08809944885979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240516

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: 2024-06-25
• Device Publish Date: 2024-06-17

On-Brand Devices [RS85 Diagnostic Ultrasound System]

• 08809521023831: USS-RS85F4F/US
• 08806167788759: USS-RS85W40/US
• 08806167787424: USS-RS85F40/US
• 08809725805363: V2.04
• 08809944885979: USS-RS85E4S/US
• 08809944885801: USS-RS85E42/US
• 08809944885757: USS-RS85D4S/US