BEUDAMED
    Product Code: OJA FDA class 2 21 CFR 880.5440

    Intravenous Extension Tubing Set

    General Hospital

    The Intravenous Extension Tubing Set is a convenience kit providing extension tubing and accessories used to extend or supplement intravenous (IV) administration sets for fluid or medication delivery in hospital and clinical settings. Classified as FDA Class 2 under regulation 21 CFR 880.5440 within the General Hospital medical specialty, it falls under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) when all criteria are met. The product code is OJA. It is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    OJA
    Device Class
    FDA class 2
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    7

    Device Characteristics

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

    Definition

    This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K873109 MODEL CC-72 CAVERNOSOMETRY/CAVERNOSOGRAPHY SET

    FEI Numbers

    This FDA classification entry is associated with 30 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.