4D/TEE module kit

GUDID 06936415912307

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06936415912307
• NIH Device Record Key: 44893d21-16ca-4678-a3c4-535ecff1d19f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4D/TEE module kit
• Version Model Number: 115-046245-01
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936415912307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171233

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: 2019-12-23
• Device Publish Date: 2019-12-14

On-Brand Devices [4D/TEE module kit]

• 06944904093086: 115-046245-00
• 06936415912307: 115-046245-01