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510(k) Data Aggregation

    K Number
    K990308
    Device Name
    ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML
    Date Cleared
    1999-12-10

    (312 days)

    Product Code
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    OF SABRATEK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ROCAP Heparin Flush Syringe 100 U/mL is indicated for use to maintain patency of indwelling venous access devices.
    Device Description
    Not Found
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    K Number
    K990390
    Device Name
    HEPARIN IV FLUSH SYRINGE, 10 U/ML \
    Date Cleared
    1999-12-10

    (304 days)

    Product Code
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    OF SABRATEK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ROCAP Heparin Flush Syringe 10 U/mL is indicated for use to maintain patency of indwelling venous access devices.
    Device Description
    Heparin Flush Syringe, 10 U/mL
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    K Number
    K984614
    Device Name
    NORMAL SALINE FLUSH SYRINGE
    Date Cleared
    1999-05-27

    (149 days)

    Product Code
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    OF SABRATEK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ROCAP Normal Saline Flush Syringe is indicated for use to maintain patency of indwelling venous access devices.
    Device Description
    Not Found
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    K Number
    K983355
    Device Name
    SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR
    Manufacturer
    Date Cleared
    1999-03-12

    (170 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    SABRATEK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Measures and displays long-term "body temperature" as calibrated to the equivalent oral temperature standard. Will not provide valid data in ambient temperatures greater than patient body temperature. Requires 30 minute warm-up before achieving accurate readings. Will not operate while exposed directly to sun or other forms of radiant heat. Measures and displays patient temperature as calibrated to the equivalent oral temperature standard. The APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor is an element of the Sabratek Corporation APM-2000 System.
    Device Description
    The document describes the Sabratek APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor, which is an electronic thermometer that measures and displays patient transcutaneous temperature. It has a digital display with a resolution of ± 0.1 F, a warm-up time of 30 minutes, and an accuracy of 0.3° F over a range of 95° F-105° F. It uses a skin surface probe and is powered by a battery.
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    K Number
    K980751
    Device Name
    SABRATEK 4040 INFUSION PUMP
    Manufacturer
    Date Cleared
    1999-02-24

    (363 days)

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

    SABRATEK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Provides controlled delivery of fluids, blood and blood products and can be used in enteral, epidural, subcutaneous, arterial and intravenous applications.
    Device Description
    Linear Peristaltic Infusion Pump
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    K Number
    K980619
    Device Name
    SABRATEK PATIENT HOME MANAGEMENT SYSTEM
    Manufacturer
    Date Cleared
    1998-08-20

    (183 days)

    Product Code
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    SABRATEK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sabratek Patient Home Monitoring System (PHMS), is a physiological data monitoring and communications system intended for use predominately in alternate care settings.
    Device Description
    The system consists of three major components as shown in Fig.1. The Ambulatory Patient Monitor (APM-2000) is an ambulatory device that monitors physiological data of the ambulatory patients. The Virtual Hospital Room Communicator (VHRC) is a data storage and transfer device that resides in a patient's home or at an alternate care center. The VHRC has the capability to detect and monitor the APM-2000. A number of peripheral devices such as a Scale, Non Invasive Blood Pressure device (NIBP), Oral Temperature probe and other devices can also be connected to the VHRC. Sabratek has selected peripheral devices with current agency rulings of substantial equivalence for use with the VHRC is accessible by a standard telephone line (POT). The Remote Device Access Software (RDAS) is a Microsoft Windows 95/NT applications program. The program interacts with the Virtual Hospital Room Communicator (VHRC) via modem and standard telephone line. The program collects the data stored in the VHRC and presents the information for review by the caregivers. The program can also control the functions of the APM-2000 and monitor the functions of other devices connected to the VHRC.
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    K Number
    K955258
    Device Name
    3030 INFUSION PUMP
    Manufacturer
    Date Cleared
    1996-06-03

    (200 days)

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

    SABRATEK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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