HM70A Diagnostic Ultrasound System

GUDID 08806167795054

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system

• Primary Device ID: 08806167795054
• NIH Device Record Key: ac62565f-dade-498b-87b6-82e6e7cb0d11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HM70A Diagnostic Ultrasound System
• Version Model Number: USS-HM7AF1U/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	08806167795054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182894

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-10
• Device Publish Date: 2019-10-11

On-Brand Devices [HM70A Diagnostic Ultrasound System]

• 08806167795047: USS-HM7AF1U/US
• 08806167795054: USS-HM7AF1U/WR
• 08806167790080: USS-HM7AF1L/US
• 08809725781582: USS-HM7NF1V/US