BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    PULSOX-300i

    DI: 00817770020547 · Model: R204P18-001 · MAXTEC, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PULSOX-300i
    Primary DI
    00817770020547
    Version / Model
    R204P18-001
    Company Name
    MAXTEC, LLC
    Labeler DUNS
    169911828
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-26
    Public Version
    6
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    eb2f7d68-0ba0-4c53-9f29-df139c6253de
    Distribution End Date
    2019-05-06

    Device Description

    Oximeter Sleep Study without Software

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DQA Oximeter

    GMDN Terms

    Code Name
    45607 Pulse oximeter

    Identifiers

    Type ID
    Primary 00817770020547