BD3000 ELST BELT LATEX FREE PRCUT


Product Overview

BD3000 ELST BELT LATEX FREE PRCUT
DOPPLEX - ACC7


Device Description

A portable device designed to be worn or carried by a patient/layperson to hold a portable medical device (e.g., long-term recorder, wireless antenna, portable oxygen equipment, urine collection bag, tracheostoma protector, infusion pump) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a wearable bag, pouch, strap, belt, headband, or clothing, or as a trolley with wheels. This is a reusable device.


Environmental Conditions

  • Handling Environment Atmospheric Pressure - millibar
    • 1060.00
    • 860.00
  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 10.00
  • Handling Environment Temperature - Degrees Celsius
    • 30.00
    • 10.00
  • Storage Environment Atmospheric Pressure - millibar
    • 1060.00
    • 860.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 93.00
    • N/A
  • Storage Environment Temperature - Degrees Celsius
    • 40.00
    • -10.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: HGM

    Device Name: System, Monitoring, Perinatal

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: OB

    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: 884.2740

    Third Party Flag: Y

    Medical Specialty: OB


    Device Identifiers

    Device Id: 05051968014030

    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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