BEUDAMED
    Product Code: PWH FDA class 2 21 CFR 880.5440

    Administrations Sets With Neuraxial Connectors

    General Hospital

    The Administrations Sets With Neuraxial Connectors are general hospital devices consisting of administration sets that incorporate ANSI/AAMI/ISO 80369-6:2016 compliant connectors specifically designed for neuraxial (spinal and epidural) applications, facilitating safe and standardized connections to prevent misconnection errors between different fluid delivery pathways. It is classified as FDA Class II under regulation 21 CFR 880.5440, requiring 510(k) premarket notification clearance and compliance with general and special controls. The product code is PWH and it falls under the General Hospital medical specialty. It is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    4
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    3
    Years Active
    6

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    Basic Information

    Product Code
    PWH
    Device Class
    FDA class 2
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K221319 BD Alaris™ Pump Epidural Infusion Set
    K211649 PCEA Syringe Set
    K172592 CADD Yellow High Volume Administration Set with NRFit connector
    K162219 CADD® Infusion Disposables Portfolio with NRFit™ connectors

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.