ViewMate

GUDID 06936415970888

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06936415970888
• NIH Device Record Key: 74afebe6-3456-467a-8831-0108268254e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViewMate
• Version Model Number: ViewMate
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936415970888 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192410

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: 2020-12-08
• Device Publish Date: 2020-11-30

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