B125/B105 V1.5 SW PACK (USB)
B1X5 Software Upgrade - V1.5
Device Description
An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OLW
Device Name: Index-Generating Electroencephalograph Software
Device Class: 2
Physical State: Electroencephalograph analysis software, either developed by 510(k) holder for use in their own hardware or licensed from another company for use in 510(k) holder's hardware. Does NOT include electrodes, amplitude-integrated electroencephalograph, automatic event-detection software, electroencephalograph software with comparative databases (normal or otherwise) or electroencephalograph software that outputs a diagnosis or classification.
Definition: Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.
Submission Type ID: 1
Review Panel: NE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Uses software algorithms, developed from and trained with specific patient datasets, to analyze electroencephalograph from 1 to 16 electrodes at sponsor-specified locations; also may output one or several signal quality indicators
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Brain
Regulation Number: 882.1400
Third Party Flag: N
Medical Specialty: NE
Code: NHQ
Device Name: Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class: 2
Physical State: N/A
Definition: A isoflurane gas analyzer is a device intended to measure the concentration of isoflurane anesthetic in a gas mixture
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.1500
Third Party Flag: Y
Medical Specialty: AN
Code: OLT
Device Name: Non-Normalizing Quantitative Electroencephalograph Software
Device Class: 2
Physical State: Electroencephalograph analysis software. Does NOT include electrodes, amplitude-integrated electroencephalograph, automatic event-detection software, software that compares data to a database (normal or otherwise) or electroencephalograph software that outputs an index, classification, diagnosis, or any clinical interpretation of the data.
Definition: Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
Submission Type ID: 1
Review Panel: NE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Uses software algorithms as a tool to analyze electroencephalograph (from user-specified electrode number and locations) and automatically calculate conventional electroencephalograph parameters. (e.g. spectral edge frequency, total power, percent alpha, asymmetry).
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Brain
Regulation Number: 882.1400
Third Party Flag: Y
Medical Specialty: NE
Code: DPZ
Device Name: Oximeter, Ear
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.2710
Third Party Flag: N
Medical Specialty: CV
Code: CBQ
Device Name: Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.1500
Third Party Flag: Y
Medical Specialty: AN
Code: CCL
Device Name: Analyzer, Gas, Oxygen, Gaseous-Phase
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.1720
Third Party Flag: Y
Medical Specialty: AN
Code: DQA
Device Name: Oximeter
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.2700
Third Party Flag: N
Medical Specialty: CV
Code: MLD
Device Name: Monitor, St Segment With Alarm
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1025
Third Party Flag: N
Medical Specialty: CV
Code: DXN
Device Name: System, Measurement, Blood-Pressure, Non-Invasive
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1130
Third Party Flag: Y
Medical Specialty: CV
Code: OMC
Device Name: Reduced- Montage Standard Electroencephalograph
Device Class: 2
Physical State: May include standard EEG recording hardware (e.g. headbox, cables, CPU, monitor and basic software (needed to display, store and archive EEG and allow user-only annotation and marking); does NOT include electrodes, more complex software used to analyze EEG or automatically detect events, EEG used for PSG or sleep studies, or EEG with > 16 electrodes or more electrodes.
Definition: Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes
Submission Type ID: 1
Review Panel: NE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Uses electrodes (less than < 16) placed on the scalp or within the brain, via user-specified and/or sponsor-specified locations, to record and display electrical activity of the brain
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Brain
Regulation Number: 882.1400
Third Party Flag: Y
Medical Specialty: NE
Code: CBR
Device Name: Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.1700
Third Party Flag: Y
Medical Specialty: AN
Code: MHX
Device Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1025
Third Party Flag: N
Medical Specialty: CV
Code: CBS
Device Name: Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.1620
Third Party Flag: Y
Medical Specialty: AN
Code: CCK
Device Name: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.1400
Third Party Flag: Y
Medical Specialty: AN
Code: DSJ
Device Name: Alarm, Blood-Pressure
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1100
Third Party Flag: Y
Medical Specialty: CV
Code: DQK
Device Name: Computer, Diagnostic, Programmable
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1425
Third Party Flag: Y
Medical Specialty: CV
Code: DSI
Device Name: Detector And Alarm, Arrhythmia
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1025
Third Party Flag: N
Medical Specialty: CV
Code: BZQ
Device Name: Monitor, Breathing Frequency
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.2375
Third Party Flag: Y
Medical Specialty: AN
Code: ORT
Device Name: Burst Suppression Detection Software For Electroencephalograph
Device Class: 2
Physical State: Electroencephalograph analysis software. Does NOT include electrodes, electroencephalograph hardware, basic electroencephalograph software (e.g. used to display, store, archive, or manually annotate data), automatic event (i.e., seizure) detection software or automatic event-detection software used as an intermediary step in source-localization analysis.
Definition: Automatically mark or identify electroencephalograph waveforms for rhythmic patterns of burst suppression in order to aid in identification of such events and help in the review and annotation of prolonged EEG traces; software can also quantify simple characteristics of the burst suppression such as inter-burst interval or count; all output subject to verification by qualified user.
Submission Type ID: 1
Review Panel: NE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Uses simple, transparent software algorithms to analyze any size montage (full or reduced) for burst suppression patterns and automatically identify areas of interest or quantify pattern characteristics.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Brain
Regulation Number: 882.1400
Third Party Flag: N
Medical Specialty: NE
Code: DRT
Device Name: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.2300
Third Party Flag: Y
Medical Specialty: CV
Code: FLL
Device Name: Thermometer, Electronic, Clinical
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HO
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 880.2910
Third Party Flag: Y
Medical Specialty: HO
Code: KRB
Device Name: Probe, Thermodilution
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1915
Third Party Flag: Y
Medical Specialty: CV
Code: NHO
Device Name: Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class: 2
Physical State: N/A
Definition: A desflurane gas analyzer is a device intended to measure the concentration of desflurane anesthetic in a gas mixture.
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.1500
Third Party Flag: Y
Medical Specialty: AN
Code: GWQ
Device Name: Full-Montage Standard Electroencephalograph
Device Class: 2
Physical State: May include standard electroencephalograph recording hardware (e.g. headbox, cables, computer, monitor, wireless) and basic software (e.g. used to display, store, archive, or manually annotate data). Does NOT include electrodes, more complex software used to analyze electroencephalograph data or automatically detect events, electroencephalograph used for polysomnography or sleep studies, or electroencephalograph with less than 16 electrodes.
Definition: Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
Submission Type ID: 1
Review Panel: NE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Uses electrodes (16 or more) placed on the scalp or within the brain, via user-specified locations, to record and display electrical activity of the brain
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Brain
Regulation Number: 882.1400
Third Party Flag: Y
Medical Specialty: NE
Code: NHP
Device Name: Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class: 2
Physical State: N/A
Definition: A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.1500
Third Party Flag: Y
Medical Specialty: AN
Code: DSK
Device Name: Computer, Blood-Pressure
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1110
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 00840682141291
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A