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510(k) Data Aggregation

    K Number
    K220695
    Device Name
    Elite Biomedical Solutions Dose Request Cord
    Manufacturer
    Elite Biomedical Solutions
    Date Cleared
    2022-04-29

    (51 days)

    Product Code
    MRZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    Elite Biomedical Solutions

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Elite Biomedical Solutions Dose Request Cord is an accessory for a syringe pump and may be used in the same environment as the corresponding pump. The healthcare worker connects the device to the pump. The patient uses the switch on the cable to signal the syringe pump to deliver medication consistent with the parameters entered into the pump by the healthcare worker. The Elite Biomedical Solutions Dose Request Cord is a non-sterile, reusable device intended for multi-patient use in adult and adolescent (over 12 years of age) population.
    Device Description
    Elite Biomedical Solutions Dose Request Cord is a replacement for the BD Alaris PCA Pump Model 8120 syringe infusion pump. Elite Biomedical Solutions does not manufacture the pump. The Dose Request Cord is an accessory for the pump and is available as a replacement part. The Dose Request Cord contains a handpiece with integral cable which plugs into the mating connector on the BD Alaris PCA Pump to allow the patient to request medication within the parameters entered into the syringe/infusion pump by the healthcare provider and the designed limits on the pumps. The Elite Biomedical Solutions Dose Request Cord has the same type of construction and technological characteristics as the predicate device, which is also a replacement bolus cable. Both the subject and predicate device are equivalent to the accessories supplied with the original pump. The Dose Request Cords are passive devices that contain no powered electronic components. They are powered by the mating equipment using low voltages to detect changes in the state of the push button. Shielding and insulation of these devices is substantially equivalent to the predicate device.
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