Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K051019
    Device Name
    SAFETY NEEDLE
    Manufacturer
    SARSTEDT, INC.
    Date Cleared
    2005-07-25

    (94 days)

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

    SARSTEDT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Safety-Needle is a single lumen needle for blood collection via venipuncture in conjunction with the S-Monovette® system. The Safety-Needle needle protector, when activated after removal of the needle from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries. The Safety-Needle is individually packaged, sterile, single-use and non-pyrogenic. The Safety-Needle is intended to be used in all hospitals and/or practices where S-Monovettes are used.
    Device Description
    The Safety-Needle is a single lumen needle for blood collection via venipuncture in conjunction with the S-Monovette® system. The Safety-Needle needle protector, when activated after removal of the needle from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries. The Safety-Needle is individually packaged, sterile, single-use and non-pyrogenic.
    Ask a Question
    K Number
    K031359
    Device Name
    S-MONOVETTE EDTA K2-GEL
    Manufacturer
    SARSTEDT, INC.
    Date Cleared
    2003-09-12

    (135 days)

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

    SARSTEDT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The S-Monovette® EDTA K2-Gel provides a means for collection, processing and transportation of a plasma specimen in a closed system. Following collection of the blood, the S-Monovette® EDTA K2-Gel is to be centrifuged such that the gel creates a barrier between the plasma and cellular components. The plasma specimen can then be removed for testing or the specimen can be transported for testing at another location without the plasma mixing with the cellular components. The plasma specimen produced by the S-Monovette® EDTA K2-Gel can be used for Nucleic Acid Testing (NAT) by methods such as PCR - Polymerase Chain Reaction or for other procedures where the laboratory has determined that a plasma specimen is appropriate.
    Device Description
    Not Found
    Ask a Question
    K Number
    K032150
    Device Name
    SAFETY-MULTIFLY
    Manufacturer
    SARSTEDT, INC.
    Date Cleared
    2003-09-12

    (60 days)

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

    SARSTEDT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Safety-Multifly® is a winged blood collection needle set with flexible tubing, an adapter for the S-Monovette® system, and an integral needle protector. The Safety-Multifly® is intended for blood collection via venipuncture. The Safety-Multifly® needle protector, when activated after removal from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries. The Safety-Multifly® is individually packaged. sterile, single-use and non-pyrogenic. The Safety-Multifly® is intended to be used in all hospitals and/or practices where S-Monovettes are used.
    Device Description
    The Safety-Multifly® is a winged blood collection needle set with flexible tubing, an adapter for the S-Monovette® system, and an integral needle protector.
    Ask a Question
    K Number
    K024237
    Device Name
    URINE MONOVETTE BORIC ACID
    Manufacturer
    SARSTEDT, INC.
    Date Cleared
    2003-04-14

    (112 days)

    Product Code
    JSM
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    SARSTEDT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Urine Monovette® boric acid is intended for use as a urine collection and transport device that maintains the integrity of the urine for delayed microbiological urine analysis
    Device Description
    Urine Monovette® boric acid
    Ask a Question
    K Number
    K003382
    Device Name
    SARSTEDT NEEDLE PROTECTOR
    Manufacturer
    SARSTEDT, INC.
    Date Cleared
    2001-03-30

    (150 days)

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

    SARSTEDT, INC.

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

    Page 1 of 1