DC-89 Diagnostic Ultrasound System

GUDID 06936415985172

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06936415985172
• NIH Device Record Key: 4d90f4f3-2157-4fa9-949c-c1fd978228d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DC-89 Diagnostic Ultrasound System
• Version Model Number: DC-89
• 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	06936415985172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192152

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: 2025-02-25
• Device Publish Date: 2025-02-17

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

• 06903053046022 - Ventilator: 2025-12-08
• 06903053046060 - Ventilator: 2025-12-08
• 06903053081917 - Diagnostic Ultrasound System: 2025-12-08
• 06903053081924 - Diagnostic Ultrasound System: 2025-12-08
• 06903053081955 - Diagnostic Ultrasound System: 2025-12-08
• 06903053081962 - Diagnostic Ultrasound System: 2025-12-08
• 06903053081979 - Diagnostic Ultrasound System: 2025-12-08
• 06903053081986 - Diagnostic Ultrasound System: 2025-12-08