Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K121478
    Device Name
    NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP
    Manufacturer
    MAPA GMBH
    Date Cleared
    2013-04-05

    (322 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAPA GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NUK Expressive Double Electric Breast Pump is intended to express milk from the breasts. It is intended for use by a single user.
    Device Description
    The NUK Expressive Double Electric Breast Pump is intended to express milk from the breasts. It is intended for use by a single user. This is accomplished by an electrical pump system generating a suck and release vacuum pattern. The suction strength is adjustable. The cycles per minute are adjustable. The electrical pumping unit of the device is connected to the breast shields via silicone tubing. The breast shield and screw housing is equipped with a flap valve separating the breast shield from the NUK breast milk container. The system is assembled in an airtight way to ensure that the system can build up vacuum when the breast shield is connected to the breast. The milk will flow through the flap back flow valve into the bottle. A voltage adaptor is provided with the device.
    Ask a Question
    K Number
    K111093
    Device Name
    BILLY BOY MALE LATEX CONDOM
    Manufacturer
    MAPA GMBH
    Date Cleared
    2011-06-03

    (45 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAPA GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BillyBoy male latex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). The BillyBoy condoms are Dotted/Beaded and New Condom models.
    Device Description
    This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is flat with a cylindrical shape. These condoms have a length of ≥175mm, a width of 52mm. The thickness is 0.10 mm. The air burst test pressure is ≥1 k Pa and air burst test volume is ≥18 dm. The primary packaging material is a foil package. The on surface lubricant is silicon oil. The term Dotted refers to the irregular surface of the condom. The irregular surface is not applied externally but is achieved in the molding process. The glass mold has an engraved pattern of semispherical pits replicated as a pattern of small round tips on the surface of the condom. This results in an exterior surface that has a pattern of small raised areas best described as a dotted pattern. The New Condom is defined as a condom of increased thickness relative to some of the other BillyBoy types.
    Ask a Question
    K Number
    K101157
    Device Name
    E-BASIC SINGLE BREAST PUMP
    Manufacturer
    MAPA GMBH
    Date Cleared
    2010-09-17

    (144 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAPA GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NUK® Easy-Flow™ Single Electric Breast Pump is intended. for use to express milk from the breast by a single user.
    Device Description
    The NUK® Easy-Flow™ Single Electric Breast Pump is intended. for use to express milk from the breast by a single use. This is accomplished by an electrical diaphragm pump generating a suck and release vacuum pattern. The suction strength is adjustable. The pumping device is sealed via a connection ring to a breast shield equipped with a valve separating the breast shield from the bottle.
    Ask a Question

    Page 1 of 1