AccessGUDID - DEVICE: Patient Monitor (06932562310096)

GUDID

Device Identifier (DI) Information

Brand Name: Patient Monitor
Version or Model: Q5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Guangdong Biolight Meditech Co., Ltd.

Primary DI Number: 06932562310096
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530120146 *Terms of Use

Device Description: 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).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

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.

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.

FDA Product Code

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Product Code	Product Code Name
MWI	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131898	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c4a48eb2-280c-4a38-a4c0-78b154d1939a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016