Identity
- Trade Name
- Patient Monitor FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- Q5 FDA UDI
- 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). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932562310096 FDA UDI
- 510(k) Number
- K131898 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose multi-parameter bedside monitor
Patient Monitor by Guangdong Biolight Meditech Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131898 also covers:
- ADVANCED PATIENT MONITOR — ADVANCED INSTRUMENTATIONS, INC.
- Patient Monitor — GUANGDONG BIOLIGHT MEDITECH CO., LTD
- Patient Monitor — GUANGDONG BIOLIGHT MEDITECH CO., LTD
- Patient Monitor — Guangdong Biolight Meditech Co., Ltd.
- Patient Monitor — Guangdong Biolight Meditech Co., Ltd.
- Patient monitor — Guangdong Biolight Meditech Co., Ltd.
- Patient monitor — Guangdong Biolight Meditech Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Guangdong Biolight Meditech Co., Ltd
Sources (1)
- FDA UDI c4a48eb2-280c-4a38-a4c0-78b154d1939a 34 fields · synced May 30, 2026