miniER7

GUDID 08809944942450

SAMSUNG MEDISON CO., LTD.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 08809944942450
• NIH Device Record Key: d18f1a4e-2030-4581-8643-84a6f5a2b6f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: miniER7
• Version Model Number: miniER7
• 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	08809944942450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250999

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: 2025-09-11
• Device Publish Date: 2025-09-03

On-Brand Devices [miniER7]

• 08809725829727: USP-E02BFAA/WR
• 08809944942450: miniER7