BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    One Degree Medical

    DI: 00860003583043 · Model: ODM-3066 · ONE DEGREE MEDICAL HOLDINGS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    One Degree Medical
    Primary DI
    00860003583043
    Version / Model
    ODM-3066
    Company Name
    ONE DEGREE MEDICAL HOLDINGS, LLC
    Labeler DUNS
    065180232
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-24
    Public Version
    1
    Public Version Date
    2021-03-04
    Public Version Status
    New
    Public Device Record Key
    41ca5998-0e58-438e-9011-2bee1fb9d527

    Device Description

    6.6L Capacity Fluid Warming Unit - ODM-3066

    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LHC Warmer, Irrigation Solution

    GMDN Terms

    Code Name
    36815 Surgical fluid heating plate

    Identifiers

    Type ID
    Primary 00860003583043