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510(k) Data Aggregation

    K Number
    K102658
    Device Name
    MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS
    Manufacturer
    THAYER MEDICAL CORP.
    Date Cleared
    2010-12-10

    (86 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    THAYER MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dual Spray MINISPACER® MDI adapter is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMD)) medication ito a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short term and long term critical care environments. The device is intended for sale by or on the order of a physician.
    Device Description
    MiniSpacer® Dual Spray MDI Adapter is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMD)) medication ito a breathing circuit.
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    K Number
    K993101
    Device Name
    LITEAIRE
    Manufacturer
    THAYER MEDICAL CORP.
    Date Cleared
    2000-10-26

    (406 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    THAYER MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LiteAire is a collapsible, disposable accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The LiteAire is a dual-valved holding chamber designed to serve three major functions: - To reduce the amount of MDI medication deposited in the patient's mouth and . throat, thus reducing the potential for unwanted local or systemic side effects. - To ease the problems that many patients have in synchronizing actuation of the . MDI canister with the start of inhalation. - To retain a significant portion of the MDI drug plume until the patient's next . inhalation, in cases where actuation and inhalation are asynchronous. The LiteAire is a non-sterile device for single-patient use.
    Device Description
    The LiteAire is a collapsible, disposable accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The LiteAire is a dual-valved holding chamber.
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    K Number
    K992722
    Device Name
    PRIMEAIRE
    Manufacturer
    THAYER MEDICAL CORP.
    Date Cleared
    1999-11-10

    (89 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    THAYER MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PrimeAire is an accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The PrimeAire is a dual-valved holding chamber. It is a non-sterile device for single-patient use,
    Device Description
    The PrimeAire is a dual-valved holding chamber. It is a non-sterile device for single-patient use.
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    K Number
    K972237
    Device Name
    HAND HELD MEDISPACER
    Manufacturer
    THAYER MEDICAL CORP.
    Date Cleared
    1997-07-31

    (91 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    THAYER MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K955805
    Device Name
    DUAL SPRAY MINISPACER
    Manufacturer
    THAYER MEDICAL CORP.
    Date Cleared
    1996-03-21

    (90 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    THAYER MEDICAL CORP.

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

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