E-CUBE

GUDID 08800013528001

Alpinion Medical Systems Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 08800013528001
• NIH Device Record Key: b20c1f83-acac-4cb0-9cdd-b8c18c4ba950
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-CUBE
• Version Model Number: E-CUBE 8
• Company DUNS: 557800655
• Company Name: Alpinion Medical Systems 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: 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	08800013528001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172732

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: 6
• Public Version Date: 2022-11-16
• Device Publish Date: 2017-12-18

On-Brand Devices [E-CUBE ]

• 08800013528001: E-CUBE 8
• 08800013527004: E-CUBE inno
• 08800013526007: E-CUBE i7
• 08800013525000: E-CUBE 15
• 08800013524003: E-CUBE 12
• 08800013523006: E-CUBE 11
• 08800013522009: E-CUBE 9
• 08800013521002: E-CUBE 7
• 08800013520005: E-CUBE 5