GE B125B105 Patient Monitor

Singapore - English - HSA (Health Sciences Authority)

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Available from:
GE HEALTHCARE PTE. LTD.
Class:
Class C medical device
Manufactured by:
GE Medical Systems Information Technologies Inc
Therapeutic area:
General Hospital
Therapeutic indications:
Portable multi-parameter unit to be 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 the direct supervision of a licensed health care practitioner. Not intended for use during MRI. Monitor can be a stand-alone monitor or interfaced to other devices via network. The monitors and displays: ECG, invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood 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, C.O. and Entrophy.
Product summary:
Device System Info:[Device with measuring function], Please refer to information provided in section "Description of intended use".; Models: B105 Patient Monitor (PTO model) - 2199000-001, B125 Patient Monitor (PTO model) - 2199000-002, B105 Patient Monitor (ATO model) - 2099000-001, B125 Patient Monitor (ATO model) - 2099000-002, B105 Basic Unit with Hemo Box 1/1 - 2099001-001, B105 Patient Monitor with GE SpO2 - 2099002-001, B105 Patient Monitor with GE SpO2 without IBP/Temp upgrade capabilty - 2099002-004, B105 Patient Monitor with Nellcor SpO2 - 2099002-003, B125 Basic Unit with Hemo Box 1/1 - 2099001-021, B125 Patient Monitor with GE SpO2 - 2099002-101, B125 Patient Monitor with GE SpO2 without IBP/Temp upgrade capabilty - 2099002-104, B125 Patient Monitor with Nellcor SpO2 - 2099002-103, TruSignal SpO2 Finger Sensor - Reusable - TS-F4-GE, TruSignal SpO2 FingerTip Sensor - Reusable - TS-SA4-GE, TruSignal SpO2 Ear Sensor - Reusable - TS-E4-GE, TruSignal SpO2 Finger Sensor - Reusable - TS-F2-GE, TruSignal SpO2 Ear Sensor - Reusable - TS-E2-GE, TruSignal SpO2 Ear Sensor - Reusable - TS-E-D, TruSignal SpO2 Finger Sensor - Reusable - TS-F-D, TruSignal SpO2 FingerTip Sensor - Reusable - TS-SA-D, TruSignal SpO2 Wrap Sensor - Reusable - TS-W-D, Trusignal SpO2 Sensitive Sensor - Reusable, 3 pcs - TS-SE-3, TrusSignal SpO2 AllFit Sensor - Adhesive, 10pcs - TS-AF-10, TrusSignal SpO2 AllFit Sensor - Adhesive, 25pc - TS-AF-25, TruSignal SpO2 Adult/Pediatric Sensor - Adhesive, 10pcs - TS-AP-10, TruSignal SpO2 Adult/Pediatric Sensor - Adhesive, 25pcs - TS-AP-25, Nellcor finger sensor, DS100A, Adult - 407705-006, Nellcor Pediatric-Infant SpO2 Sensor with Wraps - 414248-001, Nellcor SpO2 Sensor MAX-A, Adhesive, Adult (24/box) - 70124027, Nellcor SpO2 Sensor MAX-I, Adhesive, Infant (24/box) - 70124026, Nellcor SpO2 Sensor MAX-N, Adhesive, Neonatal (24/box) - 70124032, Nellcor SpO2 Sensor MAX-P, Adhesive, Pediatric (24/box) - 70124022, SPO2- SENSOR DS 100A - 70124021, Gas Sampling line, disposable, PVC/PC, 2m/7ft, 10/pkg - 2097307-001, Gas Sampling line, disposable, PVC/PC, 3m/10ft, 10/pkg - 2097307-002, Gas Sampling line, disposable, PVC/PC, 6m/20ft, 5/pkg - 2097307-003, B105 V1.5 Patient Monitor (ATO Model) - 2099000-003, B125 V1.5 Patient Monitor (ATO Model) - 2099000-004, Second Frame B1x5-F2 - 2104800-001, B105 Basic Unit with Hemo Box 1/1 - 2104200-001, B105 Patient Monitor with GE SpO2 - 2104210-001, B105 Patient Monitor with Nellcor SpO2 - 2104210-003, B105 Patient Monitor with GE SpO2 without IBP/Temp upgrade capabilty - 2104210-004, B125 Basic Unit with Hemo Box 1/1 - 2104300-001, B125 Patient Monitor with GE SpO2 - 2104310-001, B125 Patient Monitor with Nellcor SpO2 - 2104310-003, B125 Patient Monitor with GE SpO2 without IBP/Temp upgrade capabilty - 2104310-004, REUSABLE TEMPERATURE PROBE – ESOPHAGEAL/RECTAL (ADULT) - 2107176-031, REUSABLE TEMPERATURE PROBE – ESOPHAGEAL/RECTAL (PEDIATRIC) - 2107176-032, REUSABLE TEMPERATURE PROBE – SKIN (ADULT) - 2107176-033, GE Entropy Sensor, pkg of 25 pcs - M1038681, Entropy EasyFit sensor, pkg of 25 pcs - M1174413, GE Entropy cable, 3.5 m - M1050784, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, 20pcs/pkg - 8090121521, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7t, 20pcs/pkg - 8090121522, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, 20pcs/pkg - 8090121531, B125 Patient Monitor with Masimo SpO2 - 2104310-002, B105 Patient Monitor with Masimo SpO2 - 2104210-002, Mini D-fend - 8002174, D-fend Pro Water Trap - M1182629, D-fend Pro+ Water Trap, - M1200227
Authorization number:
DE0500919
Authorization date:
2017-11-29

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