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, Heart Rate(HR), Respiration Rate(RESP), Temperature(TEMP), Oxygen Saturation(BLT-SpO2), Pulse Rate(PR), Non-invasive Blood Pressure(NIBP), Carbon dioxide(CO2) of adult, pediatric and neonatal patient. FDA UDI
- Model / Reference
- M8500 FDA UDI
- Description
- The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate(HR), Respiration Rate(RESP), Temperature(TEMP), Oxygen Saturation(BLT-SpO2), Pulse Rate(PR), Non-invasive Blood Pressure(NIBP), Carbon dioxide(CO2) of adult, pediatric and neonatal patient. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932562310102 FDA UDI
- 510(k) Number
- K112803 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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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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 ecc52884-6f0b-4274-9702-bc022ef88837 34 fields · synced Jun 1, 2026