ECG Module

GUDID 06944904089607

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Patient monitoring system module, electrocardiographic

• Primary Device ID: 06944904089607
• NIH Device Record Key: 8a953e67-01de-461f-a012-2d5a0ec87ad5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG Module
• Version Model Number: 115-035885-00
• 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: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944904089607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161525

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [ECG Module]

• 06944904089607: 115-035885-00
• 06936415974596: 115-071270-00