SC5-1Ns Ultrasonic Transducer (FDA)

GUDID 06936415925895

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 06936415925895
• NIH Device Record Key: 1605375b-1e69-41ad-a95c-7f937a7ec7f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SC5-1Ns Ultrasonic Transducer (FDA)
• Version Model Number: 120-018839-00
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936415925895 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200001

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2020-12-07
• Device Publish Date: 2020-11-29

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