E-SCO-00, MODULE ASSEMBLY


Product Overview

E
NA - E-sCO-00


Device Description

A small unit dedicated to the measurement of various gas concentrations, e.g., anaesthetic agents, oxygen (O2), carbon dioxide (CO2), in inspired and expired air obtained through a sampling tube connected to a main respiratory channel (mainstream) or a side-channel (sidestream) of a breathing circuit. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot and the parent device then operates as a mainframe computer displaying the parameters measured and provided by this module.


Environmental Conditions

  • Handling Environment Atmospheric Pressure - KiloPascal
    • 106.00
    • 66.00
  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 98.00
    • 10.00
  • Handling Environment Temperature - Degrees Celsius
    • 40.00
    • 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
    • -25.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    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: 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: 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: 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: 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: 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: 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: 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


    Device Identifiers

    Device Id: 00840682104173

    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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