M7 Premium

GUDID 06944904098173

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06944904098173
• NIH Device Record Key: bcc2d9b0-038d-46b7-919f-e12d7b1ce80f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M7 Premium
• Version Model Number: M7 Premium
• 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: 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	06944904098173 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172970

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: 2018-07-25
• Device Publish Date: 2018-06-24

Devices Manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

• 06936415972417 - BeneVision Central Monitoring System: 2024-10-02
• 06944904094922 - BeneVision N1 Patient monitor: 2024-10-02
• 06944904031408 - BC-6D Hematology Control: 2023-10-27
• 06944904031422 - BC-RET Hematology Control: 2023-10-27
• 06903053039673 - L9-3s Transducer(FDA-SJM): 2023-05-30
• 06903053039680 - P8-2Ts Transducer(FDA-SJM): 2023-05-30
• 06903053039697 - SP5-1s Transducer(FDA-SJM): 2023-05-30
• 06903053039703 - P8-2s Transducer(FDA-SJM): 2023-05-30