4D Module Kit

GUDID 06944904098104

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Electromechanical device/system transport trolley

• Primary Device ID: 06944904098104
• NIH Device Record Key: d44b4c53-bfbc-49ce-9a19-d78163bb29e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4D Module Kit
• Version Model Number: 115-044346-00
• Company DUNS: 654671304
• Company Name: Shenzhen Mindray Bio-Medical Electronics 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: false
• 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

Customer Support Contacts

• Phone: +8675581888998
• Email: service@mindray.com.cn

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944904098104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182603

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: 2019-11-05
• Device Publish Date: 2019-10-28

On-Brand Devices [4D Module Kit]

• 06944904053141: 115-024666-00
• 06944904098104: 115-044346-00