HM70 EVO

GUDID 08809725790782

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system

• Primary Device ID: 08809725790782
• NIH Device Record Key: cffb99d8-9a4e-457d-8d9c-3d57377c9bdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HM70 EVO
• Version Model Number: USS-M7ENF10/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	08809725790782 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210713

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: 2021-08-12
• Device Publish Date: 2021-08-04

On-Brand Devices [HM70 EVO]

• 08809725794100: USS-M7EPC30/US
• 08809725793424: USS-M7EPF30/US
• 08809725793240: USS-M7EPF30/US
• 08809725793066: USS-M7EPCC0/US
• 08809725792960: USS-M7ENF30/US
• 08809725792786: USS-M7ENCC0/US
• 08809725792601: USS-M7ENC30/US
• 08809725792342: USS-M7ENNC0/US
• 08809725792168: USS-M7ENN30/US
• 08809725791987: USS-M7ENLC0/US
• 08809725791802: USS-M7ENL30/US
• 08809725791628: USS-M7ENFC0/US
• 08809725791420: USS-M7EPF10/US
• 08809725791246: USS-M7EPC10/US
• 08809725791147: USS-M7ENN10/US
• 08809725790966: USS-M7ENL10/US
• 08809725790782: USS-M7ENF10/US
• 08809725790607: USS-M7ENC10/US
• 08809725819070: USS-M7EPFCB/US
• 08809725818899: USS-M7EPF1B/US
• 08809725818714: USS-M7EPCCB/US
• 08809725818530: USS-M7EPC1B/US
• 08809725818332: USS-M7ENNCB/US
• 08809725818158: USS-M7ENN1B/US
• 08809725817977: USS-M7ENLCB/US
• 08809725817793: USS-M7ENL1B/US
• 08809725817618: USS-M7ENFCB/US
• 08809725817434: USS-M7ENF1B/US
• 08809725817250: USS-M7ENCCB/US
• 08809725817076: USS-M7ENC1B/US