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GE B20 Patient Monitor - HSA Registration DE0009495

Access comprehensive regulatory information for GE B20 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 DE0009495 and owned by GE Medical Systems Information Technologies. The device was registered on August 14, 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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CLASS C
DE0009495
GE B20 Patient Monitor
HSA Registration Number: DE0009495
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Product Description

Used for monitoring and recording of,and to generate alarms for,multiple physiological parameters of adult,pediatric and neonatal patients in a hospital environment and during intra-hospital transport.Intended for use under direct supervision of a licensed health care practitioner.Not intended for use during MRI. Can be a stand-alone monitor or interfaced to other devices via a network. Monitors and displays oscillometric noninvasive blood pressure (systolic, diastolic and mean arterial pressure),invasive blood pressure, end-tidal CO2, heart/pulse rate,respiration rate,ECG(incl. arrhythmia and ST segment analysis),temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion 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
DE0009495
Registration Date
August 14, 2012
Change Notification Approval Date
January 18, 2019
Retention Due Date
August 13, 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
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model Information
Model Name(s)
Dura-Cufยฎ Blood Pressure Cuffs, Dual-Tube, Submin Connector 002201 Cuff, NIBP, Dura-Cuf, Chd, 2 TB, Grn, Submin, 5/bx 002202 Cuff, NIBP, Dura-Cuf, Sm Ad, 2 TB, Royal Blu, Submin, 5/bx DURA-CUF* Cuff, NIBP, Dura-Cuf, Large Ad 2 TB, Wine, Sub-Miniature Connector DURA-CUF* Cuff, NIBP, Dura-Cuf, Ad LONG, 2 TB, Navy, Sub-Miniature Connector DURA-CUF* Cuff, NIBP, Dura-Cuf, Large Ad LONG 2 TB, Wine, Sub-Miniature Connector SOFT-CUF* Cuff, Assorted, 2-Tube Screw Connector, Ass'td Colors DURA-CUF* Child Assortment Pack, 2-Tube Screw Connector, Ass'td Colors DURA-CUF* Adult Assortment Pack, 2-Tube Screw Connector, Ass'td Colors DURA-CUF* Assortment Pack, Various Sizes, 2-Tube Screw Connector, Ass'td Colors DURA-CUF* Cuff, Adult, 2-Tube Screw Connector (w/Hanger), Navy DURA-CUF* Cuff, Adult LONG, 2-Tube Screw Connector, Navy DURA-CUF* Cuff, Adult, 2-Tube Screw Connector, Navy DURA-CUF* Cuff, Small Adult, 2-Tube Screw Connector, Royal Blue DURA-CUF* Cuff, Child, 2-Tube Screw Connector, Green DURA-CUF* Cuff, Infant, 2-Tube Screw Connector, Rust DURA-CUF* Cuff, Large Adult LONG, 2-Tube Screw Conn, Wine DURA-CUF* Cuff, Large Adult, 2-Tube Screw Connector, Wine Extension Cable for disposable temperature probes, 2.83 m / 9 ft Masimo LNOP Reusable Finger sensor LNOP/DCIP, Pediatric Masimo LNOP Reusable Finger sensor LNOP/DCI, Adult CABLE ASSY DUAL BP Thermal paper Masimo LNOP Disposable Adhesive sensor, LNOP-Adt, Adult (20/box) MASIMO SpO2-Sensor LNOP-PDT - Ped.- Adh Disposable (20/box) Masimo LNOP Reusable Multisite sensor LNOP-YI KIT ELECTRODE SOLID GEL P40CL 300 PK CABLE ASSY BP SPECTRAMED 3.6M CABLE ASSY BP UTAH 3.6M CABLE ASSY BP UTAH 1.2M Dual Temperature Cable, 0.5m / 8 in, accepts YSI 400 series probes Interconnect cable with Care connector and Masimo LNOP connector 3.6M Interconnect cable with Care connector and Masimo LNOP connector 1.2M Interconnect cable with Care connector and Masimo LNOP connector 2.4M CABLE ASSY ECG MLT-LNK 3/5 LEAD 3.6M AHA CABLE ASSY ECG MLT-LNK 3/5 LEAD 3.6M IEC CABLE ASSY ECG 3 LEAD NEO 3.6M AHA CABLE ASSY ECG 3 LEAD NEO 3.6M IEC AIR HOSE, NIBP, ADULT, 3.6M AIR HOSE, NIBP, ADULT, 1.2M AIR HOSE, NIBP, ADULT, 3.6M, Screw Connectors AIR HOSE, NIBP, ADULT, 1.2M, Screw Connectors AIR HOSE, NIBP, NEONATAL 2.4M AIR HOSE, NIBP, NEONATAL 1.2M AIR HOSE, NIBP, NEONATAL 3.6M Masimo LNOP Disposable Adhesive sensor, LNOP-Neo-L, Neonatal/ adult suitable (20/box) Masimo LNOP Disposable Adhesive sensor, LNOP-NeoPt-L, Neonatal (20/box) CABLE ASSY ECG 3 LEAD W/GRAB AHA CABLE ASSY ECG 3 LEAD W/GRAB IEC CABLE ASSY BP ABBOTT TRANSPAC-IV 3.6M CABLE ASSY BP ABBOTT TRANSPAC-IV 1.2M CABLE ASSY BP EDWARDS LS TRUWAVE 3.6M
Model Identifier(s)
002200 002201 002202 002204 002206 002207 002695 002697 002698 002699 002771 002772 002774 002779 002781 002783 002784 002791 165641 2002799-001 2002800-001 2005772-001 2009828-046 2010458-001 2010459-001 2010463-001 2014782-001 2016995-001 2016997-001 2016997-002 2016998-001 2017002-001 2017002-002 2017002-003 2017003-001 2017003-003 2017004-001 2017004-003 2017008-001 2017008-002 2017008-003 2017008-004 2017009-001 2017009-002 2017009-003 2017089-001 2017090-001 2021141-001 2021141-002 2021196-001 2021196-002 2021197-001