L13-3Ns Ultrasonic Transducer (FDA)

GUDID 06936415925864

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 06936415925864
• NIH Device Record Key: 52d407f1-3c5b-470b-8a2b-f2262ba71b30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L13-3Ns Ultrasonic Transducer (FDA)
• Version Model Number: 120-018835-00
• 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	06936415925864 [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.

• 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
• 06903053039710 - CW2s Transducer(FDA-SJM): 2023-05-30
• 06903053039727 - L16-4Hs Transducer(FDA-SJM): 2023-05-30