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510(k) Data Aggregation

    K Number
    K992145
    Device Name
    ECOMED SCALP VEIN SET
    Manufacturer
    GREINER MEDITECH, INC.
    Date Cleared
    1999-10-14

    (112 days)

    Product Code
    FPA, FOZ
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREINER MEDITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ecomed® Scalp Vein Set is a winged blood collection needle with a tubing used for the collection of venous blood.
    Device Description
    The Ecomed® Scalp Vein Set is a sterile winged needle bonded to a flexible tubing with a female luer adapter. The female luer is provided with a protective cap on the end.
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    K Number
    K992244
    Device Name
    GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE
    Manufacturer
    GREINER MEDITECH, INC.
    Date Cleared
    1999-07-26

    (24 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREINER MEDITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing a 3.2% sodium citrate solution, intended to collect, transport, and process whole blood for coagulation testing. The MiniCollect® Coagulation tube is intended for citrate anticoagulated whole blood samples for Coagulation Assays.
    Device Description
    The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing a 3.2% sodium citrate solution, intended to collect, transport, and process whole blood for coagulation testing.
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    K Number
    K991843
    Device Name
    GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE
    Manufacturer
    GREINER MEDITECH, INC.
    Date Cleared
    1999-06-25

    (28 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREINER MEDITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To collect, transport, separate and process capillary blood for testing plasma in the clinical laboratory.
    Device Description
    The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing lithium heparin anticoagulant and an inert acrylic barrier material, intended to collect, transport, separate and process capillary blood for testing serum.
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    K Number
    K983952
    Device Name
    GREINER VACUETTE BLOOD COLLECTION TUBE
    Manufacturer
    GREINER MEDITECH, INC.
    Date Cleared
    1998-12-28

    (53 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREINER MEDITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To collect, transport, store and process blood for testing serum in the clinical laboratory. In addition, tubes are suitable for therapeutic drug monitoring.
    Device Description
    The Greiner VACUETTE® blood collection tube with clot activator and gel separator is an evacuated blood collection device containing a clot activator and an inert polymeric barrier material.
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    K Number
    K982998
    Device Name
    GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE
    Manufacturer
    GREINER MEDITECH, INC.
    Date Cleared
    1998-10-21

    (55 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREINER MEDITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To collect, transport, separate and process capillary blood for testing serum in the clinical laboratory.
    Device Description
    The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing a clot activator and an inert acrylic barrier material, intended to collect, transport, separate and process capillary blood for testing serum.
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    K Number
    K982999
    Device Name
    GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE
    Manufacturer
    GREINER MEDITECH, INC.
    Date Cleared
    1998-10-16

    (50 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREINER MEDITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To collect, transport, store, and evaluate capillary blood specimens for hematology and lead tests.
    Device Description
    The Greiner MiniCollect® EDTA K3 tube is a non-sterile, non-evacuated blood collection device containing EDTA K3 anticoagulant additive, and is intended for use in evaluations of capillary blood specimens. The Greiner MiniCollect® tube cap is made from rubber and has "cross-cuts" to allow for direct collection into and sampling from the tube without having to remove the cap.
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    K Number
    K981619
    Device Name
    VACUETTE MULTIPLE SAMPLE LUER ADAPTER
    Manufacturer
    GREINER MEDITECH, INC.
    Date Cleared
    1998-07-15

    (70 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREINER MEDITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in venous blood collection with attached butterfly needle or luer needle.
    Device Description
    The Greiner Vacuette® Multiple Sample Luer Adapter is a device of which one end is a plastic male luer adapter and the other end is a sharpened stainless steel needle. The needle end of the luer adapter is epoxy bonded to the plastic upper end (hub) and is covered by a rubber sheath. The luer adapter is threaded into a needle holder for the purposes of attaching a butterfly needle for use in venous blood collection. The luer adapter is a sterile, single-use disposable device.
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    K Number
    K980768
    Device Name
    VACUETTE HOLDEX
    Manufacturer
    GREINER MEDITECH, INC.
    Date Cleared
    1998-04-09

    (41 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREINER MEDITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used in routine venipuncture procedures using butterfly needles and/or hypodermic luer needles.
    Device Description
    The VACUETTE® Holdex® Holder is a single-use disposable plastic device to be used in routine venipuncture procedures using butterfly needles or luer needles. Sterile and non-sterile versions are available. The sterile version of VACUETTE® Holdex® is manufactured from polystyrene plastic and is sterilized by electronic beam. The non-sterile version is autoclavable and is manufactured from polycarbonate plastic.
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    K Number
    K974873
    Device Name
    VACUETTE (MULTI-USE HOLDER)
    Manufacturer
    GREINER MEDITECH, INC.
    Date Cleared
    1998-02-05

    (38 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREINER MEDITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used in routine venipuncture procedures
    Device Description
    non-sterile reusable plastic device to be used in routine venipuncture procedures.
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    K Number
    K973620
    Device Name
    VACUETTE MULTI-SAMPLE NEEDLE
    Manufacturer
    GREINER MEDITECH, INC.
    Date Cleared
    1997-12-17

    (85 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREINER MEDITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in venous blood collection
    Device Description
    a tubular stainless steel device sharpened at both ends, one end to withdraw blood, and the other end to be threaded into a needle holder which is used to guide the needle into an evacuated blood collection tube.
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