ASTRAL EXTERNAL BATTERY


Product Overview

ASTRAL EXTERNAL BATTERY
ASTRAL - 27919


Device Description

A group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet; it might additionally have features to facilitate transport of the device being powered (e.g., push handles, storage shelves, mounting rails). It is typically used during a transport situation (e.g., a neonatal incubator) or to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.


Environmental Conditions

  • Storage Environment Atmospheric Pressure - KiloPascal
    • 106.00
    • 70.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 93.00
    • 5.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 122.00
    • -4.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: NOU

    Device Name: Continuous, Ventilator, Home Use

    Device Class: 2

    Physical State: N/A

    Definition: This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.

    Submission Type ID: 1

    Review Panel: AN

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 868.5895

    Third Party Flag: N

    Medical Specialty: AN


    Code: CBK

    Device Name: Ventilator, Continuous, Facility Use

    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: Y

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 868.5895

    Third Party Flag: N

    Medical Specialty: AN


    Device Identifiers

    Device Id: 00619498279197

    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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