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510(k) Data Aggregation

    K Number
    K093244
    Device Name
    UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX
    Manufacturer
    GERATHERM MEDICAL AG
    Date Cleared
    2010-10-19

    (369 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    GERATHERM MEDICAL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Geratherm UniqueTemp® is a thermal regulating system for adult patients in order to prevent hypothermia in the operating theater. It is suitable for pre-, intra- and post-operative use. The device is not life-supporting. It is intended for use by appropriately trained healthcare professionals in clinical environments.
    Device Description
    Geratherm UniqueTemp® has been developed for the prevention of hypothermia. The Geratherm warming blankets can be used for covering the patient in various ways without restricting the surgical area and provide active warming to the patient. All the blankets can be freely combined. The flexibility of the blankets makes it possible to warm the patient, even if complicated positioning on the operating table is required. After being placed over the patient, Geratherm UniqueTemp® can itself be covered with surgical drapes. Geratherm UniqueTemp® is suitable for use with adult patients of all sizes. The blankets should not be used for children. Geratherm UniqueTemp® is intended to be used during lengthy operations as well as by hypothermic patients. The device is not life-supporting. Geratherm UniqueTemp® should be operated only by qualified medical professionals. The Geratherm UniqueTemp9 consists of the following components: Control unit, Holding claw, Mains cable, Arm/shoulder blanket, Reusable cover for arm/shoulder blanket, Torso blanket, Reusable cover for torso blanket, Leg blankets, Reusable cover for leg blankets, Connecting cable, Body temperature sensor. The Controller is made of anodized aluminum (colorless or black); furthermore, the control unit has a glass screen. All blankets and covers have a PU coated material. The connecting cable is made of silicone.
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    K Number
    K093694
    Device Name
    GERATHERM UNIQUERESC
    Manufacturer
    GERATHERM MEDICAL AG
    Date Cleared
    2010-09-20

    (294 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    GERATHERM MEDICAL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Geratherm UniqueResc is a thermal regulating system for adult patients in order to prevent hypothermia in preclinical settings or treatments on-site. It is intended for use while at the rescue scene, during patient transport by air or ground to a medical facility or e.g. during disaster operation in first aid tents. The device should be used by appropriately trained healthcare professionals.
    Device Description
    Geratherm UniqueResc* has been developed for the prevention and treatment of hypothermia. The warming blankets are light-weight, comfortable and easily transportable. The use of several blankets per patient is possible. The flexibility of the blankets makes it possible to warm the patient even during complicated rescue operating conditions. Geratherm UniqueResc is suitable for use with adult patients of all sizes. The blankets should not be used for children. Geratherm UniqueResc should be operated only by qualified medical professionals. The benefits of Geratherm UniqueResc+ are: Active warming applied to the patient from superior side. State-of-the-art conductive material provides exceptionally uniform heating. Microprocessor-controlled Functions noiselessly Simple and easy to use Highly durable and easy to clean The optional Geratherm AC~DC Power Supply Adapter (see section 12.3 of the instruction manual for detailed description) functions with all alternating current mains power sources (100~240VAC, 50~60 Hz). Other optional power sources include 15VDC 2590 Li-Ion Battery and 12VDC-28VDC Onboard Power.
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