ScvO2 function upgrade kit

GUDID 06944904086187

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Patient monitoring system module, intracranial pressure

• Primary Device ID: 06944904086187
• NIH Device Record Key: 0e167e9e-d45b-4f7c-a4e2-02853823f3e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScvO2 function upgrade kit
• Version Model Number: 115-007590-00
• 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	06944904086187 [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 [ScvO2 function upgrade kit]

• 06944904086187: 115-007590-00
• 06944904096773: 115-046900-00