DEVICE: Patient Monitor (06932562310140)
Device Identifier (DI) Information
Patient Monitor
M9000A
In Commercial Distribution
Guangdong Biolight Meditech Co., Ltd.
M9000A
In Commercial Distribution
Guangdong Biolight Meditech Co., Ltd.
The Monitor is used to monitor patient’s physiological parameters such as ECG、Respiration Rate( RESP)、Oxygen Saturation (BLT-SpO2)、Non-invasive Blood Pressure (NIBP)、Invasive Blood Pressure( IBP)、Temperature (TEMP)、Carbon dioxide (CO2) 、Anesthetic Gas (AG )and Impedance Cardiograph (ICG) continuously
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K100046 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
2d5c831d-36d8-4108-935d-b141b6c80972
July 06, 2018
3
September 22, 2016
July 06, 2018
3
September 22, 2016
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