minisono

GUDID 08800013531001

Alpinion Medical Systems Co., Ltd.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 08800013531001
• NIH Device Record Key: 635bdff3-1eda-4945-bc71-69a43a320997
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: minisono
• Version Model Number: minisono C1-6
• Company DUNS: 557800655
• Company Name: Alpinion Medical Systems 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800013531001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182845

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-11-16
• Device Publish Date: 2019-01-07

On-Brand Devices [minisono]

• 08800013531001: minisono C1-6
• 08800013530004: minisono L3-12