DEVICE: COMEN (06945429010046)
Device Identifier (DI) Information
COMEN
C50
In Commercial Distribution
Shenzhen Comen Medical Instruments Co., Ltd.
C50
In Commercial Distribution
Shenzhen Comen Medical Instruments Co., Ltd.
No description.
Device Characteristics
| MR Unsafe | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| DSJ | Alarm, Blood-Pressure |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| DSI | Detector And Alarm, Arrhythmia |
| MLD | Monitor, St Segment With Alarm |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
| DQA | Oximeter |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) |
| DSK | Computer, Blood-Pressure |
| DPS | Electrocardiograph |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) |
| NHO | Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function |
| NHP | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) |
| DSB | Plethysmograph, Impedance |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) |
| OLW | Index-Generating Electroencephalograph Software |
| FLL | Thermometer, Electronic, Clinical |
| GXY | Electrode, Cutaneous |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
840ee35e-7a59-4876-96f2-9bfa18f62f9f
November 10, 2021
3
February 27, 2020
November 10, 2021
3
February 27, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined