BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SIMMONS Clinical Care

    DI: M368770000S1 · Model: 770000S · GF HEALTH PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SIMMONS Clinical Care
    Primary DI
    M368770000S1
    Version / Model
    770000S
    Company Name
    GF HEALTH PRODUCTS, INC.
    Labeler DUNS
    132016168
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-31
    Public Version
    3
    Public Version Date
    2019-07-25
    Public Version Status
    Update
    Public Device Record Key
    7e6629ca-f128-4390-9278-ba46f71281cc

    Device Description

    Clinical Max Low Air Loss with Alternating Pressure System

    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
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    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
    FNM Mattress, Air Flotation, Alternating Pressure

    GMDN Terms

    Code Name
    47478 Alternating-pressure bed mattress overlay system

    Identifiers

    Type ID
    Package M368770000S2
    Primary M368770000S1

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -15 – 50 Degrees Celsius