Patient Monitor

GUDID 06932562310096

The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG(3-lead, 5-lead, 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate(HR), Respiration Rate(RESP), Temperature(TEMP), Pulse Oxygen Saturation(Masimo-SpO2), Pulse Rate(PR), Non-invasive Blood Pressure(NIBP), Invasive Blood Pressure(IBP), Carbon dioxide(CO2), Anesthetic Gas(AG), Impedance Cardiograph(ICG), Cerebral State Index(CSI), Bispectral Index(BIS), Total Hemoglobin(SpHb), Carboxyhemoglobin(SpCO), and Methemoglobin(SpMet).

Guangdong Biolight Meditech Co., Ltd.

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 06932562310096
• NIH Device Record Key: c4a48eb2-280c-4a38-a4c0-78b154d1939a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Monitor
• Version Model Number: Q5
• Company DUNS: 530120146
• Company Name: Guangdong Biolight Meditech Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06932562310096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131898

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Patient Monitor]

• 06932562310232: M8000
• 06932562310218: Q7
• 06932562310201: Q3
• 06932562310195: AnyView A3
• 06932562310188: AnyView A5
• 06932562310171: AnyView A8
• 06932562310164: M7000
• 06932562310140: The Monitor is used to monitor patient’s physiological parameters such as ECG、Respiration Ra
• 06932562310133: The Monitor is used to monitor patient’s physiological parameters such as ECG、Respiration Ra
• 06932562310126: The vital signs monitor is intended to be used for monitoring, displaying, reviewing, storing an
• 06932562310119: The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming o
• 06932562310102: The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming o
• 06932562310096: The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming o
• 06932562310089: The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming o
• 06932562310331: M9000