BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PremierPro Air Transfer Mat

    DI: 00818566019219 · Model: 3711 · SVS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PremierPro Air Transfer Mat
    Primary DI
    00818566019219
    Version / Model
    3711
    Catalog Number
    3711
    Company Name
    SVS LLC
    Labeler DUNS
    831375089
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-04-10
    Public Version
    2
    Public Version Date
    2019-02-14
    Public Version Status
    Update
    Public Device Record Key
    78a393b7-3514-4239-8ba9-a15d9bb0864d

    Device Description

    INTENDED USE/ CONTRAINDICATIONS PremierPro™ Air Transfer Mats are indicated for patients: Who are unable to transfer or turn by their own effort, both assisted and unassisted. Whose size and weight present possible risks to caregivers involved in the transfer of the patient. PRECAUTIONS & WARNINGS Use two or more caregivers during patient transfers. Do not use transfer mat until user manual is reviewed. Do not leave patient unattended on inflated transfer mat. Do not attempt to move patient on uninflated transfer mat. The maximum safe working load for all PremierPro™ Air Transfer Mats is l,000lbs (450kg). AIR SUPPLY Air supply units may be compatible with Premier™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed. MRI SAFETY PremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors: Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh. Safety strap buckles are constructed from Polypropylene. Air supply fasteners are manufactured from non-ferrous metal. Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts. Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI. CLEANING The PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FRZ Device, Patient Transfer, Powered

    GMDN Terms

    Code Name
    37160 Patient transfer system, powered

    Identifiers

    Type ID
    Package 10818566019216
    Primary 00818566019219

    Customer Contacts

    Phone
    1-855-531-7699
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Length 39 Inch