BEUDAMED
    Product Code: IHJ FDA class 1 21 CFR 864.3010

    Blender, Sputum

    Pathology

    A Sputum Blender is a laboratory instrument used in pathology to homogenize sputum specimens, liquefying the viscous mucus so that the sample can be processed for microbiological culture, cytological examination, or diagnostic testing for respiratory conditions. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IHJ, regulated under 21 CFR 864.3010, within the Pathology medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    IHJ
    Device Class
    FDA class 1
    Regulation Number
    864.3010
    Medical Specialty
    Pathology
    Review Panel
    PA
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.