Diagnostic Ultrasound system

GUDID 06944904096971

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06944904096971
• NIH Device Record Key: 375d7a8f-87f2-4ffd-ac6e-e27b93cb19bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diagnostic Ultrasound system
• Version Model Number: ACUSON Bonsai
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944904096971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171034

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: 2020-10-05
• Device Publish Date: 2020-09-25

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

• 06903053001786 - ZS3 Elite Diagnostic Ultrasound System: 2025-02-26
• 06903053001793 - ZS3KP Elite Diagnostic Ultrasound System: 2025-02-26
• 06903053001809 - ZS4 Diagnostic Ultrasound System: 2025-02-26
• 06936415910389 - DC-80A Diagnostic Ultrasound System: 2025-02-26
• 06936415912499 - DC-65 Diagnostic Ultrasound System: 2025-02-26
• 06936415925628 - DC-80A Exp Diagnostic Ultrasound System: 2025-02-26
• 06936415925635 - DC-80A Pro Diagnostic Ultrasound System: 2025-02-26
• 06936415925642 - DC-81 Diagnostic Ultrasound System: 2025-02-26