Product Overview

NA - 2040427-004


Device Description

A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.


Environmental Conditions

  • Handling Environment Atmospheric Pressure - KiloPascal
    • 106.00
    • 70.00
  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 15.00
  • Handling Environment Temperature - Degrees Celsius
    • 35.00
    • 10.00
  • Storage Environment Atmospheric Pressure - KiloPascal
    • 106.00
    • 50.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 10.00
  • Storage Environment Temperature - Degrees Celsius
    • 60.00
    • -20.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    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: 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: BZK

    Device Name: Spirometer, Monitoring (W/Wo Alarm)

    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: 868.1850

    Third Party Flag: Y

    Medical Specialty: AN


    Code: KOI

    Device Name: Stimulator, Nerve, Peripheral, Electric

    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: 868.2775

    Third Party Flag: Y

    Medical Specialty: AN


    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: 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: 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: BZL

    Device Name: Computer, Oxygen-Uptake

    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: 868.1730

    Third Party Flag: Y

    Medical Specialty: AN


    Code: DXG

    Device Name: Computer, Diagnostic, Pre-Programmed, Single-Function

    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: 870.1435

    Third Party Flag: Y

    Medical Specialty: CV


    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: 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: 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: 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: 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: 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: 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: 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


    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: 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: CAP

    Device Name: Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

    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: 868.2600

    Third Party Flag: Y

    Medical Specialty: AN


    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: 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: 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: 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: 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: 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: 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: 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: 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: GWJ

    Device Name: Stimulator, Auditory, Evoked Response

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: NE

    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: 882.1900

    Third Party Flag: Y

    Medical Specialty: NE


    Code: DPS

    Device Name: Electrocardiograph

    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: 870.2340

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00840682104456

    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


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