Product Overview

MY-CUF - MY-T1-2A


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 typically wrapped around the upper arm of the patient. This is a single-use device.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 15.00
  • Storage Environment Temperature - Degrees Celsius
    • 55.00
    • -20.00

  • Device Sizes

  • Thigh
    • Thigh


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DXQ

    Device Name: Blood Pressure Cuff

    Device Class: 2

    Physical State: N/A

    Definition: A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.

    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: 870.1120

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00840682116947

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00840682116220

    Package Quantity: 20

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: N/A


    Device Id: 00840682116220

    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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