4D and TEE Driver Module Board

GUDID 06944904099583

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06944904099583
• NIH Device Record Key: fce5d3a0-341a-46ad-86dd-7f9d19c35113
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4D and TEE Driver Module Board
• Version Model Number: 115-042870-00
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944904099583 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163690

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: 2018-08-24
• Device Publish Date: 2018-07-24

On-Brand Devices [4D and TEE Driver Module Board]

• 06944904099583: 115-042870-00
• 06944904089713: 115-024451-00