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510(k) Data Aggregation

    K Number
    K220558
    Device Name
    Blood Administration Sets
    Manufacturer
    Baxter Healthcare Corporation
    Date Cleared
    2022-11-17

    (262 days)

    Product Code
    BRZ
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    BRZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Applicable to Product Code 2N3383: For the administration of blood components or solutions from a container into the patient's vascular system through a vascular access device. Applicable to Product Code 2N3385: For the administration of blood components or solutions from a container into the patient's vascular system through a vasular access device. Only for use with Neonates and Pediatios. Not for use in Trauma situations.
    Device Description
    Baxter's IV Administration Sets (Blood Administration Sets) are single use, nonpyrogenic, sterile disposable devices intended for the administration of fluids from a container into the patient's vascular system. They can be used to administer solutions, blood, and blood products to patients. The proposed blood set configuration (Product Code 2N3385) consists of non-DEHP PVC (< 0.1% DEHP) tubing, blood chamber, 200 um Filter, Clearlink Luer Activated Valve (LAV), notch clamp, female Luer lock, dual anti-syphon valve, male Luer lock, and a filter vented cap for a male Luer lock. It can be used to administer solutions, blood, and blood products to the patient. The blood set (2N3385) will be used for syringe-based infusion. The clinician attaches the blood set to a blood bag and manually draws blood into a syringe. The blood is then delivered into the patient's vascular system through a vascular access device.
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    K Number
    K210335
    Device Name
    Blood Administration Set
    Manufacturer
    Baxter Healthcare Corporation
    Date Cleared
    2021-06-10

    (125 days)

    Product Code
    BRZ
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    BRZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.
    Device Description
    The proposed device is an IV Administration Set (Blood Administration Set). It is a single use, non-pyrogenic, sterile disposable device intended for the administration of fluids from a container into the patient's vascular system. It can be used to administer solutions, blood, blood products to patients of all ages ranges - neonatal, pediatric, and adult. The proposed set consists of non-DEHP PVC (< 0.1% DEHP) tubing, a notch clamp, a female Luer lock, a non-vented cap for a female Luer lock, a male Luer lock, and a filter vented cap for a male Luer lock.
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    K Number
    K132905
    Device Name
    200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER
    Manufacturer
    ARTERIOCYTE MEDICAL SYSTEMS, INC.
    Date Cleared
    2013-10-04

    (18 days)

    Product Code
    BRZ
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    BRZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 200 Micron Blood Component Filter and Syringe Adapter is designed to filter clots and other particles from blood and blood components for delivery.
    Device Description
    Tubing assembly with a 200 micron filter connected by tubing with clamp and luer on one end and a purchased piston syringe on the other end.
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    K Number
    K083349
    Device Name
    BLOOD TRANSFUSION SET
    Manufacturer
    SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
    Date Cleared
    2009-04-10

    (148 days)

    Product Code
    BRZ
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    BRZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blood Transfusion Set is used to administer blood from a container (plastic bag or glass bottle) to a patient's vascular system through a needle or catheter inserted into a vein.
    Device Description
    The proposed device is plastic, disposable and sterile blood transfusion set, which is intended to be used to administer the blood from the container to a patient's vascular system through a needle or catheter inserted into a vein via gravity method. The blood transfusion set consists of protective cap of the closure-piercing device, closure piercing device, tubing, drip, flow regulator, transfusion needle and needle sheath. In addition, there are two kinds of the transfusion set, one has a drug-adding feature and the other hasn't. There are two specifications of transfusion needle, which are 0.9# transfusion needle and 1.2# transfusion needle. The proposed device is provided sterilized.
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    K Number
    K073339
    Device Name
    BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR
    Manufacturer
    FENWAL, INC.
    Date Cleared
    2008-03-03

    (96 days)

    Product Code
    BRZ
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    BRZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Administration of blood and blood by-products.
    Device Description
    Fenwal markets a broad range of intravascular administration sets for administration of I.V. solutions or blood involving hundreds of different sets marketed. While the design of these sets differs for each particular application, they are all based on a common basic design involving polyvinyl chloride extruded tubings, with attendant extruded or injection molded connecting parts of other thermoplastics (such as acrylic, ABS, nylon, and similar polymers) plus latex and synthetic rubber injection sites.
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    K Number
    K041496
    Device Name
    PENTATRASFU BLOOD TRANSFUSION SETS
    Manufacturer
    PENTAFERTE S.P.A
    Date Cleared
    2005-06-30

    (391 days)

    Product Code
    BRZ
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    BRZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To Administer Blood to the patient's vascular system. To administer Blood and Blood Derivatives into a patient's vascular system
    Device Description
    The PENTATRASFU™ Blood Transfusion Sets are Single Use, Non-toxic, Sterile, Non-Pyrogenic devices used to administer Blood to a patient's vascular system through a Needle or Catheter inserted into a vein.
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    K Number
    K050805
    Device Name
    30 ML OR 60 ML PEDI-SYRINGE FILTER
    Manufacturer
    BLOOD PRODUCTS SPECIALTIES LLC
    Date Cleared
    2005-06-20

    (82 days)

    Product Code
    BRZ, FMF
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    BRZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blood Product Specialties Pedi-Syringe Filter™ is intended to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma and cryoprecipitate for pediatric and/or neonatal transfusion.
    Device Description
    Tubing assembly with a 150 micron filter connected by tubing to a spike at one end and connected by tubing to a piston syringe at the other end. Between the filter and the spike there is a clamp.
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    K Number
    K050115
    Device Name
    BLOOD HAND PUMP ADMINISTRATION SET
    Manufacturer
    CARDINAL HEALTH, ALARIS PRODUCTS
    Date Cleared
    2005-04-01

    (73 days)

    Product Code
    BRZ
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    BRZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A single use, disposable, blood administration set with pressure pump and blood filter used to deliver blood/blood products rapidly through use of the pressure pump and/or gravity flow.
    Device Description
    The Blood Hand Pump Administration Set is a single use, disposable, gravity blood set with a blood filter and hand pressure pump. The addition of the hand pressure pump provides the capability for delivering blood/blood products more rapidly by compressing the pump by hand.
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    K Number
    K023039
    Device Name
    BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015
    Manufacturer
    TUTA HEALTHCARE PTY LIMITED
    Date Cleared
    2002-11-07

    (56 days)

    Product Code
    BRZ
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    BRZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Administration of Intravenous fluids and drugs. The Tuta Healthcare Pty. Limited Blood Administration Set is a device used to administer fluids, blood and blood products from a container to a patient's vascular system Through a catheter or venous access system inserted into a vein. Use of Needle-Free Access site may aide in the prevention of needlestick injury.
    Device Description
    The Tuta Healthcare Blood/Solution Administration Set is designed administer fluids from a container to a patient's vascular system through a needle catheter inserted into a vein. The pump helps to control the rate of flow of fluids from the container to the patient.
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    K Number
    K000685
    Device Name
    CHARTER MEDICAL NEONATAL SYRINGE SET
    Manufacturer
    CHARTER MEDICAL, LTD.
    Date Cleared
    2000-08-15

    (168 days)

    Product Code
    BRZ
    Regulation Number
    880.5440
    Why did this record match?
    Product Code :

    BRZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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