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510(k) Data Aggregation

    K Number
    K974190
    Device Name
    CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER
    Manufacturer
    CONSOLIDATED PRODUCTS & SERVICES, INC.
    Date Cleared
    1997-11-19

    (15 days)

    Product Code
    IMD
    Regulation Number
    890.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    **CONSOLIDATED PRODUCTS **& SERVICES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CP&S Disposable Ice Pack Limb Kit Transporter provides an environment above freezing for a severed body part while being transported to the hospital emergency room or replantation surgery.
    Device Description
    The CP&S Disposable Instant Ice Pack Limb Kit Transporter is an instant ice pack with an added pouch for the insertion of a severed body part for transport to the hospital emergency room or replantation surgery. The Instant Cold Pack Limb Kit Transporter is activated in the same manner as the Disposable Instant Cold Pack and provides cooling for the severed limb within the gauze lined zip lock top bag. A cool environment above freezing is maintained for approximately 30 minutes. The additional pouch does not affect the safety or efficacy of the disposable Instant Cold Pack.
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