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510(k) Data Aggregation

    K Number
    K062091
    Device Name
    POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
    Manufacturer
    POROUS MEDIA CORP.
    Date Cleared
    2006-08-08

    (15 days)

    Product Code
    BTT
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    POROUS MEDIA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Humidifiers are defined as a device that is intended to add moisture to the breathing gases for administration to a patient. The HUMIDIFLOW™ is intended to be installed on oxygen concentrators to add moisture to the breathing gases for administration to a patient.
    Device Description
    The HUMIDIFLOW™ is a new device that humidifies oxygen. The device attaches to the inlet side of the air compressor and to the outlet oxygen used in oxygen concentrators and operates as a mass exchanger to transfer the room air humidity to the patient gas.
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    K Number
    K061426
    Device Name
    OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47
    Manufacturer
    POROUS MEDIA CORP.
    Date Cleared
    2006-06-05

    (13 days)

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

    POROUS MEDIA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Porous Media oxygen concentrator filters are replacement filters intended for use in oxygen concentrator machines to help remove contaminants, including air borne bacteria and other particulate debris from an air stream. When used with oxygen concentrator machines, the replacement filters may be used in the home, nursing home, patient care facility, etc.
    Device Description
    Room air is drawn into the compressor through the bacterial intake filter. From the compressor, the air passes through the compressor filter, if one is installed on the machine, and proceeds to the sieve beds. The sieve beds condition the air, by removing nitrogen from the air stream, which results in a higher concentration of oxygen. The air then passes through the final filter before being supplied to the patient.
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    K Number
    K990276
    Device Name
    POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
    Manufacturer
    POROUS MEDIA CORP.
    Date Cleared
    1999-10-01

    (246 days)

    Product Code
    KRJ
    Regulation Number
    870.4280
    Why did this record match?
    Applicant Name (Manufacturer) :

    POROUS MEDIA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - The filter is intended for use only with non-cellular fluid in the extra-. corporeal circuit prior to the initiation of cardiopulmonary bypass. - The DPB30 disposable pre-bypass filter has been designed for single . use and should be discarded once the circuit is primed - The device is intended for adult population only. .
    Device Description
    DPB30 Disposable Pre-bypass Filter
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    K Number
    K982385
    Device Name
    POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER
    Manufacturer
    POROUS MEDIA CORP.
    Date Cleared
    1999-02-01

    (207 days)

    Product Code
    KRJ, NOV
    Regulation Number
    870.4280
    Why did this record match?
    Applicant Name (Manufacturer) :

    POROUS MEDIA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - . THE FILTER IS INTENDED FOR USE ONLY WITH NON-CELLULAR FLUID IN THE EXTRACORPOREAL CIRCUIT PRIOR TO THE INITIATION OF CARDIOPULMONARY BYPASS. - THE DPB20™ DISPOSABLE PRE-BYPASS FILTER HAS . BEEN DESIGNED FOR SINGLE USE AND SHOULD BE DISCARDED ONCE THE CIRCUIT IS PRIMED.
    Device Description
    Not Found
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    K Number
    K982127
    Device Name
    POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER
    Manufacturer
    POROUS MEDIA CORP.
    Date Cleared
    1998-06-23

    (6 days)

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

    POROUS MEDIA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THIS DISPOSABLE FILTER HAS BEEN DESIGNED FOR SINGLE USE AS A MAIN FLOW FILTER, INSPIRATORY AND EXHALATION FILTER. THIS FILTER IS HYDROPHOBIC. FOR USE WITH RESPIRATORY THERAPY AND ANESTHESIA APPLICATIONS. HELPS PROTECT PATIENTS FROM RESPIRATORY AND ANESTHESIA VENTILATOR CONTAMINANTS. VERSATILE, DISPOSABLE, ENCONOMY OF USE - HELPS PROTECT PATIENT, VENTILATORY EQUIPMENT, AND HOSPITAL STAFF.
    Device Description
    One Disposable Breathing Circuit Bacterial Filter. CLEAR PLASTIC SHELL ALLOWS FOR VISUAL INSPECTION OF THE FILTER MEDIUM.
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    K Number
    K965020
    Device Name
    POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER
    Manufacturer
    POROUS MEDIA CORP.
    Date Cleared
    1997-03-14

    (88 days)

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

    POROUS MEDIA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K964979
    Device Name
    POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER
    Manufacturer
    POROUS MEDIA CORP.
    Date Cleared
    1997-03-11

    (89 days)

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

    POROUS MEDIA CORP.

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