BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Microlife

    DI: 00810445030001 · Model: MedGem · MICROLIFE USA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Microlife
    Primary DI
    00810445030001
    Version / Model
    MedGem
    Company Name
    MICROLIFE USA, INC.
    Labeler DUNS
    176387785
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-14
    Public Version
    1
    Public Version Date
    2023-06-22
    Public Version Status
    New
    Public Device Record Key
    abaf0d84-b7ac-4333-8342-5bc278bce15f

    Device Description

    MedGem is an indirect calorimeter, which is intended to measure oxygen uptake for measurement of patient resting metabolic rate (RMR).

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    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
    BZL Computer, Oxygen-Uptake

    GMDN Terms

    Code Name
    46876 Indirect calorimeter

    Identifiers

    Type ID
    Primary 00810445030001