BEUDAMED
    Product Code: NZG FDA class 2 21 CFR 880.5145

    Bassinet, Hospital

    General Hospital

    The Bassinet, Hospital (product code NZG) is a Class 2 general hospital device designed for use with pediatric patients in hospital nurseries, constructed from materials suitable for hospital use. Regulated under 21 CFR 880.5145 within the General Hospital specialty, it requires 510(k) clearance and is not GMP-exempt. The device carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    0
    FEI Numbers
    25
    Registration Numbers
    25
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    NZG
    Device Class
    FDA class 2
    Regulation Number
    880.5145
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    4

    Device Characteristics

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

    Definition

    Intended for medical purposes designed for the use of a pediatric patient made of all construction materials used in a hospital nursery.

    FEI Numbers

    This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.