DEVICE: Patient Monitor (06932562310119)

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Device Identifier (DI) Information

Patient Monitor
M9500

Guangdong Biolight Meditech Co., Ltd.
06932562310119
GS1
1
The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate(HR), Respiration Rate(RESP), Temperature(TEMP), Pulse Oxygen Saturation(BLT-SpO2), Pulse Rate(PR), Non-invasive Blood Pressure(NIBP), Invasive Blood Pressure( IBP) and Carbon dioxide(CO2) of adult, pediatric and neonatal patient.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Single-patient physiologic monitoring system An assembly of devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient. It typically includes a central station monitor that receives, consolidates, and displays the information, and a bedside patient monitor; it often includes portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring of an ambulatory patient. The system is used to evaluate and observe trends in a compromised or unstable patient in intensive or general healthcare settings.
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FDA Product Code

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Product Code Product Code Name
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 22, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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