BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PremierPro Air Transfer Mats

    DI: 00818566019264 · Model: 3730 · PRESTIGE AMERITECH, LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    PremierPro Air Transfer Mats
    Primary DI
    00818566019264
    Version / Model
    3730
    Catalog Number
    3730
    Company Name
    PRESTIGE AMERITECH, LTD.
    Labeler DUNS
    199692794
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-04-10
    Public Version
    3
    Public Version Date
    2026-03-23
    Public Version Status
    Update
    Public Device Record Key
    4d8948d9-4cda-49a3-b440-2c71d05d2b2f

    Device Description

    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. Use 2 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 is l000lbs. AIR SUPPLY units may be compatible 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. May be used in situations that require transferring patients undergoing Magnetic Resonance Imaging. 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: Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh. 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. Reusable models may be wiped down with disinfectant or laundered between patients. When laundering, a water and bleach mixture of 100:1 may be used. Wash the mat using hot water (s160° F/ 65° C) with a cold-water rinse. When drying, the dryer temperature should be s140° F/60° C. Drying time should be set at 60 minutes or less. The "Wrinkle Free" setting on the dryer should be set to "Off". The PremierPro Reusable Air Transfer Mat may also be air dried. The Air Transfer Mats may show signs of wear after repeated drying.

    Device Characteristics

    Single Use
    No
    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
    Primary 00818566019264

    Customer Contacts

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

    Device Sizes

    Type Value Unit Text
    Length 28 Inch