Cuff & Bladder-6023,Adult, Navy


Product Overview

Cuff & Bladder
Advantage™ - 850-6023


Device Description

A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 85.00
    • 15.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 131.00
    • -4.00

  • Device Sizes

  • Wide Range Adult, 22-45.9cm
    • Wide Range Adult, 22-45.9cm


    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


    Device Identifiers

    Device Id: 00634782562991

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00634782063184

    Package Quantity: 15

    Package Discontinue Date: 6/14/2023 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: Master Case


    Device Id: 00634782063184

    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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