COVERS,TEMP PROBE

GUDID 06944904031330

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 06944904031330
• NIH Device Record Key: b41f0e47-58ce-4b07-bb8b-b72754e7b175
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COVERS,TEMP PROBE
• Version Model Number: M09A-20-62124
• Company DUNS: 654671304
• Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Device Count: 20
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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
• 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	06944904007892 [Primary]
GS1	06944904007908 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	06944904031330 [Package]; Contains: 06944904007892; Package: [10 Units]; In Commercial Distribution
GS1	06944904090863 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170712

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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: 2020-05-07
• Device Publish Date: 2020-04-29

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• 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