HM70 EVO Diagnostic Ultrasound System

GUDID 08809944880561

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system

• Primary Device ID: 08809944880561
• NIH Device Record Key: b510cd75-9dc6-465c-849b-b23dd43dc8db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HM70 EVO Diagnostic Ultrasound System
• Version Model Number: USS-M7ENNCC/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	08809944880561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233112

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: 2024-01-11
• Device Publish Date: 2024-01-03

On-Brand Devices [HM70 EVO Diagnostic Ultrasound System]

• 08809944882428: USS-M7EVN1C/US
• 08809944882305: USS-M7EVC1C/US
• 08809944882183: USS-M7EPFCC/US
• 08809944882008: USS-M7EPF1C/US
• 08809944881827: USS-M7EPCCC/US
• 08809944880745: USS-M7EPC1C/US
• 08809944880561: USS-M7ENNCC/US
• 08809944880387: USS-M7ENN1C/US
• 08809944880202: USS-M7ENLCC/US
• 08809944880028: USS-M7ENL1C/US
• 08809944879848: USS-M7ENFCC/US
• 08809944879664: USS-M7ENF1C/US
• 08809944879480: USS-M7ENCCC/US
• 08809944879305: USS-M7ENC1C/US