COMEN

Basic Information

• Brand Name: COMEN
• Primary DI: 06945429010053
• Version / Model: C80
• Company Name: Shenzhen Comen Medical Instruments Co., Ltd.
• Labeler DUNS: 529823362
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-27
• Public Version: 3
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 01ccfbca-f066-415f-aede-b0b1b40a439e

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MLD	Monitor, St Segment With Alarm	Cardiovascular	870.1025	2
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	870.1025	2
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	870.1025	2
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	870.2300	2
DSJ	Alarm, Blood-Pressure	Cardiovascular	870.1100	2
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	868.1500	2
OLW	Index-Generating Electroencephalograph Software	Neurology	882.1400	2
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	868.1500	2
GXY	Electrode, Cutaneous	Neurology	882.1320	2
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2
DQA	Oximeter	Cardiovascular	870.2700	2
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	868.1700	2
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	868.1400	2
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	868.1500	2
DSK	Computer, Blood-Pressure	Cardiovascular	870.1110	2
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	868.1620	2
DPS	Electrocardiograph	Cardiovascular	870.2340	2
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	868.1720	2
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	870.1435	2
DSB	Plethysmograph, Impedance	Cardiovascular	870.2770	2
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36872	Multiple vital physiological parameter monitoring system, clinical	An assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06945429010053	GS1