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510(k) Data Aggregation

    K Number
    K090156
    Device Name
    ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000
    Date Cleared
    2009-09-01

    (222 days)

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

    **WCM WASTE **& COMPLIANCE MANAGEMENT, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Isolyser Sharps Management System (SMS) is a disposable overthe-counter sharps container that is intended for the safe and effective disposal of used medical sharps. The SMS sharps containers are designed to safely and securely contain used medical sharps prior to removal and subsequent disposal. The SMS is marketed in four (4) different models: (1) Sharps Room System (SRS) 800. .98 liters: (2) Sharps Management System (SMS) 2400, 3.3 liters; (3) Sharps Management System (SMS) 4000, 5.97 liters; and (4) Sharps Management System (SMS) 10000, 10.47 liters. Each SMS model includes a water-based acrylamide solution that, when mixed with the provided catalysts, creates a polymer that encapsulates used medical sharps. Once the polymer has formed, the entire SMS container, including its contents, may be disposed in a user's ordinary trash in most states. It is the user's responsibility to dispose of the SMS container in accordance with Federal. State and Local regulations. The SRS 800, SMS 2400, SMS 4000, SMS 10000 are intended for use by small quantity health care providers such as dentists, medical doctors, veterinarians, and laboratories. The SMS sharps containers are not intended for reuse.
    Device Description
    The Isolyser SMS is a disposable over-the-counter sharps container that is intended for the safe and effective disposal of used medical sharps. The SMS is marketed in four (4) different models: (1) Sharps Room System (SRS) 800. .98 liters: (2) Sharps Management System (SMS) 2400, 3.3 liters; (3) Sharps Management System (SMS) 4000, 5.97 liters; and (4) Sharps Management System (SMS) 10000, 10.47 liters. The SMS containers are marketed for use in the offices, exam, and patient rooms of small quantity healthcare providers such as medical doctors, dentists, veterinarians, and laboratories. The SMS sharps containers are not intended for reuse. The SMS's container is stable, puncture resistant, and leak-proof on the sides and bottom. Used medical sharps are placed vertically into the opening on the top of the container and dropped into an acrylamide solution that is contained inside the container. Once the SMS container has been filled with used medical sharps. users: add the provided catalyst packages to the acrylamide solution inside the container; securely place the lid onto the container; shake the container for ten (10) seconds; and allow the polymer to form overnight. Once the polymer has formed, the entire SMS container, including its contents, may be disposed in a user's ordinary trash in most states. It is the user's responsibility to dispose of the SMS container in accordance with Federal, State and Local regulations. The overall design and specifications for the Isolyser SMS meet OSHA Bloodborne Pathogens Standard as well as the American Society for Testing and Materials Puncture Resistance Standard F2132-01(2008). All SMS containers have BIOHAZARD warning labels clearly visible with lettering in contrasting color and are affixed by adhesives to the sides of the SMS container.
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    K Number
    K090157
    Device Name
    ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5.
    Date Cleared
    2009-05-04

    (102 days)

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

    **WCM WASTE **& COMPLIANCE MANAGEMENT, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Isolyser Sharps Management Systems SMSm is a single-use, disposable, over-the-counter sharps container intended for use in clinical and non-clinical settings for the disposal of contaminated sharps and/or medical/red-bag wastes. The SMSm is marketed in five (5) different models: (1) Home Sharps Management (HSM) 800m, .98 liters, 3.45 x 2.72 x 7.29 (in.); (2) Sharps Management System (SMS) 2400m, 3.3 liters, 5 x 5x 10 (in.); (3) Sharps Mariagement System (SMS) 4000m, 5.97 liters, 8.47 x 5.99 x 8.87 (in.); (4) Sharps Management System (SMS) 10000m, 10.47 liters, 8.51 x 5.99 x 14.32 (in.); and (5) Sharps Management System (SMS) 5.3m, 21.1 liters, 11.93 x 9.87 x 14.68 (in.). Each SMSm model is designed to safely and securely contain used medical sharps and/or medical/red-bag wastes prior to removal and subsequent disposal. The SMS 5.3m is intended only for the storage and disposal of filled approved sharps containers and/or medical/red-bag wastes. Once an empty SMSm container has been filled with used medical sharps and/or medical/red-bag wastes, the entire SMSm container is intended to be packaged and mailed-back to WCM Waste and Compliance Management, Inc. for proper disposal. The HSM 800m, SMS 2400m, SMS 4000m, SMS 10000m, and SMS 5.3m are intended for home use by home health care providers and for use by small quantity health care providers such as dentists, medical doctors, veterinarians, and laboratories. The SMSm sharps containers are not intended for reuse.
    Device Description
    The Isolyser Home Sharps Management (HSM) 800m; Sharps Management System (SMS) 2400m; Sharps Management System (SMS) 4000m; Sharps Management System (SMS) 10000m are disposable non-reusable sharps containers that are intended to provide for safe and effective disposal of medical sharps and/or medical/red-bag wastes. The Isolyser Sharps Management System (SMS) 5.3m is intended only for the storage and disposal of filled approved sharps containers and/or medical/red-bag wastes. The SMS 5.3m is not intended for the direct disposal of used medical sharps. The HSM 800m, SMS 2400m, SMS 4000m, SMS 10000m, and SMS 5.3m are marketed for home use by home healthcare providers and for use in the offices, exam. and patient rooms of small quantity generators such as medical doctors, dentists, veterinarians, and laboratories. The SMSm container is stable, puncture resistant (SMS 5,3m not tested) and leak-proof on the sides and bottom. Used medical sharps and/or medical/red-bag wastes are placed vertically into the opening on the top of the container. Once placed into the container, the SMSm does not require users to reach by hand into the container to retrieve contaminated sharps and/or medical/red-bag wastes. Once the container is full, the SMSm is intended to be mailed back to WCM Waste and Compliance Management, Inc. for proper disposal. The overall design and specifications for the Isolyser SMSm meet OSHA Bloodborne Pathogens Standard as well as the American Society for Testing and Materials Standard F2132-01(2008) (SMS 5.3m not tested). All SMSm containers have BIOHAZARD warning labels clearly visible with lettering in contrasting color and are affixed by adhesives to the sides of the SMSm container.
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