CO upgrd pkg/no accssry

GUDID 06944904085999

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Patient monitoring system module, cardiac output

• Primary Device ID: 06944904085999
• NIH Device Record Key: 6aae0497-0477-48fe-8ece-a594ab2c8d6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CO upgrd pkg/no accssry
• Version Model Number: 115-030584-00
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944904085999 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143195

FDA Product Code

• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

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 [CO upgrd pkg/no accssry]

• 06944904085999: 115-030584-00
• 06936415919139: 115-047285-00