EV2-12

GUDID 08809880020021

SAMSUNG MEDISON CO., LTD.

Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 08809880020021
• NIH Device Record Key: d0656447-ed46-4cc4-90b3-d6c8a2808c8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EV2-12
• Version Model Number: USP-VF2CF1A/WR
• 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	08809880020021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230084

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: 2023-05-04
• Device Publish Date: 2023-04-26

Devices Manufactured by SAMSUNG MEDISON CO., LTD.

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• 08809944879848 - HM70 EVO Diagnostic Ultrasound System: 2024-01-11
• 08809944880028 - HM70 EVO Diagnostic Ultrasound System: 2024-01-11
• 08809944880202 - HM70 EVO Diagnostic Ultrasound System: 2024-01-11
• 08809944880387 - HM70 EVO Diagnostic Ultrasound System: 2024-01-11
• 08809944880561 - HM70 EVO Diagnostic Ultrasound System: 2024-01-11