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GE B40 Patient Monitor - HSA Registration DE0010325

Access comprehensive regulatory information for GE B40 Patient Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0010325 and owned by GE Medical Systems Information Technologies. The device was registered on September 06, 2012.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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HSA Official Data
CLASS C
DE0010325
GE B40 Patient Monitor
HSA Registration Number: DE0010325
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Product Description

A portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, neonatal patients in a hospital environment and during intra-hospital transport. The B40 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring(including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room /Myocardial/ Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate), and Entropy.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0010325
Registration Date
September 06, 2012
Change Notification Approval Date
January 18, 2019
Retention Due Date
September 05, 2025
Product Owner
Short Name
GE Medical Systems
Address
8200 West Tower Avenue Milwaukee, WI 53223, UNITED STATES
Registrant
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Address
2 Kallang Avene, CT Hub, #05-04, SINGAPORE 339407 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model Information
Model Name(s)
YSI Temperature Cable SPO2 (Pulse Oximetry),Masimo Reusable Sensors SPO2 (Pulse Oximetry),Masimo Reusable Sensors Invasive pressure Thermal paper SPO2 (Pulse Oximetry), Masimo Adhesive Sensor SPO2 (Pulse Oximetry), Masimo Adhesive Sensor SPO2 (Pulse Oximetry),Masimo Reusable Sensors Electrodes Invasive pressure Invasive pressure Invasive pressure YSI Temperature Cable SPO2 (Pulse Oximetry), Masimo Cables SPO2 (Pulse Oximetry), Masimo Cables SPO2 (Pulse Oximetry), Masimo Cables Multi-Link Cables (ECG accessories) Multi-Link Cables (ECG accessories) Multi-Link Cables (ECG accessories) Multi-Link Cables (ECG accessories) Blood Pressure Tubing (Air Hoses) (NIBP Accessories) Blood Pressure Tubing (Air Hoses) (NIBP Accessories) Blood Pressure Tubing (Air Hoses) (NIBP Accessories) Blood Pressure Tubing (Air Hoses) (NIBP Accessories) Blood Pressure Tubing (Air Hoses) (NIBP Accessories) Blood Pressure Tubing (Air Hoses) (NIBP Accessories) Blood Pressure Tubing (Air Hoses) (NIBP Accessories) SPO2 (Pulse Oximetry), Masimo Adhesive Sensor SPO2 (Pulse Oximetry), Masimo Adhesive Sensor Multi-Link Cables (ECG accessories) Multi-Link Cables (ECG accessories) Invasive pressure Invasive pressure Invasive pressure Invasive pressure SPO2 (Pulse Oximetry), Nellcor Interface Cables SPO2 (Pulse Oximetry), Nellcor Interface Cables Multi-Link ESU Cable (ECG accessories) Multi-Link ESU Cable (ECG accessories) SPO2 (Pulse Oximetry), Masimo Adhesive Sensor SPO2 (Pulse Oximetry), Masimo Adhesive Sensor SPO2 (Pulse Oximetry), Masimo Adhesive Sensor SPO2 (Pulse Oximetry),Masimo Reusable Sensors SPO2 (Pulse Oximetry),Masimo Reusable Sensors SPO2 (Pulse Oximetry),Masimo Reusable Sensors SPO2 (Pulse Oximetry), Masimo Cables SPO2 (Pulse Oximetry), Masimo Adhesive Sensor SPO2 (Pulse Oximetry), Masimo Adhesive Sensor SPO2 (Pulse Oximetry),Masimo Reusable Sensors Starter Kits (NIBP Accessories) Starter Kits (NIBP Accessories) Starter Kits (NIBP Accessories) Starter Kits (NIBP Accessories) SPO2 (Pulse Oximetry), Masimo Adhesive Sensor SPO2 (Pulse Oximetry), Masimo Adhesive Sensor SPO2 (Pulse Oximetry), Masimo Adhesive Sensor Blood Pressure Tubing (Air Hoses) (NIBP Accessories) Blood Pressure Tubing (Air Hoses) (NIBP Accessories) Blood Pressure Tubing (Air Hoses) (NIBP Accessories) Blood Pressure Tubing (Air Hoses) (NIBP Accessories) Blood Pressure Tubing (Air Hoses) (NIBP Accessories) B40 W/O IBP English B40 W/ IBP English Extension rack with E-module slot Extension rack with thermal recorder Extension rack with E-module slot and thermal recorder Extension rack only No extension rack Sidestream CO2 Module, E-miniC W/ OCRG No network Network for iCentral (S/5 network) Network for CIC (CARESCAPE network) Network for HL7 only Network for CIC (CARESCAPE network) with HL7 output B40 W/O IBP & Temp English Airway Gas Option Module, N-CAiO-00, ENGLISH B40 Patient Monitor B40 Patient Monitor B40 Patient Monitor B40 Patient Monitor B40 Patient Monitor B40 Patient Monitor B40 Patient Monitor B40 Patient Monitor B40 Patient Monitor B40 Patient Monitor B40 Patient Monitor W/ OCRG Network for iCentral (S/5 network) Network for CIC (CARESCAPE network) Network for HL7 only Network for CIC (CARESCAPE network) with HL7 output No network Gas Sampling Line, disposable, PVC/PE, 2m/7ft Gas Sampling Line, disposable, PVC/PE, 3m/10ft Gas Sampling Line, disposable, PVC/PE, 6m/20ft SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector SOFT-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube B40 Patient Monitor B40 Patient Monitor CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube NEONATAL Classic-Cuf® Blood Pressure Cuffs, Dual-Tube, Male Slip Connectors SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, Submin Connector Disposable airway adapters SPO2 (Pulse Oximetry), Nellcor Reusable Sensors SPO2 (Pulse Oximetry), Nellcor Reusable Sensors Multi-Link ECG Cable Adapters (ECG accessories) Multi-Link ECG Cable Adapters (ECG accessories) ECG Leadwire (ECG accessories) ECG Leadwire (ECG accessories) ECG Leadwire (ECG accessories) ECG Leadwire (ECG accessories) SPO2 (Pulse Oximetry), Nellcor Reusable Sensors SPO2 (Pulse Oximetry), Nellcor Adhesive Sensor SPO2 (Pulse Oximetry), Nellcor Adhesive Sensor SPO2 (Pulse Oximetry), Nellcor Adhesive Sensor SPO2 (Pulse Oximetry), Nellcor Adhesive Sensor CO2 sampling lines CO2 sampling lines anesthesia gas sampling line anesthesia gas sampling line anesthesia gas sampling line anesthesia gas sampling line anesthesia gas sampling line Disposable airway adapters Disposable airway adapters Disposable airway adapters Disposable airway adapters Airway Low dead space adapters Airway Low dead space adapters Airway Low dead space adapters Airway Low dead space adapters Airway Low dead space adapters Airway Low dead space adapters Airway gas anesthesia gas sampling line Exhaust Lines Exhaust Lines Airway gas CO2 sampling lines CO2 sampling lines CO2 sampling lines CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube CLASSIC-CUF® Blood Pressure Cuffs, Dual-Tube Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, DinaClick Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, DinaClick Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, DinaClick Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, DinaClick Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, DinaClick Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, DinaClick Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, DinaClick Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, DinaClick Connector Dura-Cuf® Blood Pressure Cuffs, Dual-Tube, DinaClick Connector Entropy™ module, E-ENTROPY Temperature Disposable Probe Temperature Disposable Probe Temperature Disposable Probe Temperature Reusable Probe Temperature Reusable Probe Temperature Reusable Probe Exhaust Lines Entropy accessories Entropy accessories CO2 sampling lines Entropy accessories Airway gas CARESCAPE Respiratory Module, E-sCO CARESCAPE Respiratory Module, E-sCAiO CARESCAPE Resp. Module, E-sCOV CARESCAPE Resp. Module, E-sCAiOV Airway gas Entropy™ module, E-ENTROPY Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube Clinical Systems SENSA-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SOFT-CUF® Blood Pressure Cuffs, Dual-Tube SPO2 (Pulse Oximetry), TruSignal SPO2 (Pulse Oximetry), TruSignal SPO2 (Pulse Oximetry), TruSignal SPO2 (Pulse Oximetry), TruSignal SPO2 (Pulse Oximetry), TruSignal SPO2 (Pulse Oximetry), TruSignal SPO2 (Pulse Oximetry), TruSignal SPO2 (Pulse Oximetry), TruSignal SPO2 (Pulse Oximetry), TruSignal SPO2 (Pulse Oximetry), TruSignal SPO2 (Pulse Oximetry), TruSignal SPO2 (Pulse Oximetry), TruSignal SPO2 (Pulse Oximetry), TruSignal SPO2 (Pulse Oximetry), TruSignal SPO2 (Pulse Oximetry), TruSignal
Model Identifier(s)
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