Color Doppler Ultrasound System

GUDID 06972174670010

Shenzhen Well.D Medical Electronics Co.,Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06972174670010
• NIH Device Record Key: 3d8f63e3-6dd5-4c6b-a72f-7e4b3d562973
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Color Doppler Ultrasound System
• Version Model Number: mEye1
• Company DUNS: 421472085
• Company Name: Shenzhen Well.D Medical Electronics 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972174670010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182165

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2019-02-28
• Device Publish Date: 2019-01-28

On-Brand Devices [Color Doppler Ultrasound System]

• 06972174670027: mEye2
• 06972174670010: mEye1