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510(k) Data Aggregation

    K Number
    K051712
    Device Name
    MODEL 2800 PFT FILTER
    Manufacturer
    AIR SAFETY LTD
    Date Cleared
    2005-09-01

    (66 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIR SAFETY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Model 2800 is indicated for use with pulmonary function testing equipment, to filter air between the patient's exhaled air and the testing equipment. Single patient use.
    Device Description
    The EMS PFT Filter is a compact, electrostatic filter with various end-fitting adaptable to various pulmonary function testing circuits. It has 75 ml deadspace of 0.7 cm H2O at 720 lpm per ATS spirometry guidelines or 0.5 cm H2O @ 60 lpm. There are various connectors to allow connection to various PFT equipment. Single patient use.
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    K Number
    K050953
    Device Name
    AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE
    Manufacturer
    AIR SAFETY LTD
    Date Cleared
    2005-06-29

    (75 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIR SAFETY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Filtration of exhaled gases in the ventilator circuit. Model 3000/06 to be placed in the exhalation pathway of the ventilator circuit where filtration of the expired gases is desired. Filter is reusable up to 100 times, extended use as determined by the increase in airflow resistance, which is determined during self testing (SST) mode of the ventilator. For use with the Series 700 and 7200 NPB ventilators. Cleaning method -- autoclaved -- 30 minutes with 3 minutes at 134°C. Environment of Use --Hospital, Sub-acute Institutions
    Device Description
    The Air Safety Model 3000/06 HEPA filter is a multi-use, reusable ventilator in-line filter which The An Bareey Indust side of the PB 700 series and 7200 ventilators. It can be cleaned by steam ecomeets in the ennation are 1 year service life. It has standard 22 mm tubing connectors and it has a clear housing. It contains the Air Safety standard Multipleat media which has been HEPA tested for enting performance according to BS 3928 Sodium Flame for Air filters and in accordance to DOE 3202-97 and ASTM D2986 - DOP. In addition BFE and VFE testing has been performed by 1902 5202 77 and in the substantial equivalence to the predicate devices.
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    K Number
    K040712
    Device Name
    AIR SAFETY HEPA, MODEL 3500
    Manufacturer
    AIR SAFETY LTD
    Date Cleared
    2004-06-03

    (77 days)

    Product Code
    MOD
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIR SAFETY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Model 3500/01 is a replacement part for the ventilator. The Inlet Filter removes particles of 0.3 micron size (or larger) from entering the ventilator. It is a HEPA grade particulate filter for use with the NPB Achieva or LP 10 ventilators. The filter is in the gas flow pathway. As a HEPA particulate filter for the inlet air to be supplied to the patient from the ventilator.
    Device Description
    Model 3500/01 is a replacement part for the ventilator. The Inlet Filter removes particles of 0.3 micron size (or larger) from entering the ventilator. It is a HEPA grade particulate filter for the NPB Achieva or LP 10 ventilators, which is in the gas flow pathway. Screw-in cartridge to fit the inlet air filter port of the ventilator housing.
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    K Number
    K033008
    Device Name
    AIR SAFETY HEPA AND NON-HEPA FILTERS
    Manufacturer
    AIR SAFETY LTD
    Date Cleared
    2004-05-13

    (230 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIR SAFETY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Anesthesia / Respiratory Filters For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired. Model – HEPA filter 3000/04 – Single patient use for exhalation limb of circuit on NPB 700 series ventilators Models – HEPA filters - 6500/01, 6888/01, 8222/01, 8444/01 Model – Non-HEPA filters - 4000/01 Single patient use up to 24 hours. Patient tidal volumes > 150 ml, when applicable.
    Device Description
    The Air Safety HEPA and Non-HEPA filters are available in multiple sizes and shapes, and incorporate standard 15 / 22 mm connectors with or without a gas sampling luer port. Some models adapt to fit ventilator exhalation limb only. The depth (HEPA filtration) filter uses a pleated paper fiber for filtration. Filters are tested for rating performance according to EN 13328 Salt for Breathing System filtration performance. The "HEPA" performance was also tested in accordance to DOE-3025-99, DOE-3020-97 and ASTM D2986 - DOP. The electrostatic (non-HEPA filtration) filters are tested by Nelson Laboratories for BFE and VFE.
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