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510(k) Data Aggregation

    K Number
    K970739
    Device Name
    RMI HEMOCONCENTRATOR PREFERENCE PACK
    Manufacturer
    RESEARCH MEDICAL, INC.
    Date Cleared
    1997-07-08

    (130 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESEARCH MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RMI Hemoconcentrator Preference Pack is a medical device convenience pack that is intended to allow RMI customers to specify their preference for one or more of the following devices that will be provided in their hemoconcentrator pack : - Rinse-Required Hemoconcentrator with tubing set and prime lines, LCH-500-A - Pre-Rinsed BioFilterTM 140 Hemoconcentrator, HEM-001 - 24 inch Hemoconcentrator Tubing Set, TS-024 - 36 inch Hemoconcentrator Tubing Set, TS-036 - Hemoconcentrator Adapter Set, HEM-001 Adapters -- - Hemoconcentrator Waste Bag, WB-001 - BioFilterTM 140 with Adapter Set, HEM-001-A - - BioFilterTM 140 with 24 inch Tubing Set, HEM-024 ( - BioFilter™ 140 with 36 inch Tubing Set, HEM-036 I - BioFilterTM 140 with 24 inch Tubing Set and Maste Bag, HEM-O24-B - Biofilter TM 140 with 36 inch Tubing Set and Waste Bag, HEM-024-B - Hemoconcentrator Pole Mount, WEW OV - Hemoconcentrator Pole Mount, HEM-OIH The hemoconcentrator is intended for relief or mitigation of overhadration in patients undergoing cardiopulmonary bypass procedures and to decrease the concentration of plasma water in blood.
    Device Description
    Not Found
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    K Number
    K964833
    Device Name
    RMI DUAL FLUID IRRIGATING SYRINGE
    Manufacturer
    RESEARCH MEDICAL, INC.
    Date Cleared
    1997-02-19

    (79 days)

    Product Code
    KYZ
    Regulation Number
    880.6960
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESEARCH MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The RMI Dual Fluid Irrigating Syringe consists of two Becton Dickinson 10cc syringes pre-assembled in a PVC holster. The dual lumen applicator tip of the Dual Fluid Irrigating Syringe consists of two separate lines of tecoflex tubing that form a "Y" connection, then remain parallel to deliver two separate solutions or fluids simultaneously onto the surgical site. A three-way stopcock is connected to each syringe to accommodate attachable 36" fluid transfer sets used to draw prescribed solutions or fluids into each syringe. The plunger ends of the 10cc syringes are coupled together with an LDPE yoke. The RMI Dual Fluid Irrigating Syringe is ethylene oxide (EtO) sterilized and is sold as a disposable, single use, non-pyrogenic device.
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    K Number
    K961927
    Device Name
    RMI HEMOCONCENTRACTOR TUBING SET
    Manufacturer
    RESEARCH MEDICAL, INC.
    Date Cleared
    1996-08-13

    (88 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESEARCH MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RMI Hemoconcentrator Tubing Set is a set of tubing, fittings and connectors that is used to interconnect an RMI hemoconcentrator to: 1) a location in an extracorporeal circuit that will sustain blood flows up to 500 ml/min, 2) either a cardiotomy or venous reservoir, and 3) a graduated ultrafiltrate collection container.
    Device Description
    The RMI Hemoconcentrator Tubing Set is a set of tubing, fittings and connectors that is used to interconnect an RMI hemoconcentrator to: 1) a location in an extracorporeal circuit that will sustain blood flows up to 500 ml/min, 2) either a cardiotomy or venous reservoir, and 3) a graduated ultrafiltrate collection container. The RMI Hemoconcentrator Tubing Set is provided sterile and non-pyrogenic.
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    K Number
    K960098
    Device Name
    RMI INTERNAL MAMMARY ARTERY CANNULA
    Manufacturer
    RESEARCH MEDICAL, INC.
    Date Cleared
    1996-03-26

    (75 days)

    Product Code
    DQR
    Regulation Number
    870.1300
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESEARCH MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The RMI Internal Mammary Artery Cannula is composed of a chrome-plated brass female luer hub and 304 stainless steel tubing with smooth bulb tip.
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