BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    O2Health fingertip pulse oximeter

    DI: 04713072980748 · Model: DB11-B · DELBIO INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    O2Health fingertip pulse oximeter
    Primary DI
    04713072980748
    Version / Model
    DB11-B
    Company Name
    DELBIO INC.
    Labeler DUNS
    656777740
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-16
    Public Version
    3
    Public Version Date
    2023-11-22
    Public Version Status
    Update
    Public Device Record Key
    e33e811d-33ec-48e5-890a-1e5492e6972a

    Device Description

    O2Health fingertip pulse oximeter, model: DB11-

    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
    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
    DQA Oximeter

    GMDN Terms

    Code Name
    45607 Pulse oximeter

    Identifiers

    Type ID
    Primary 04713072980748

    Premarket Submissions

    Submission Number Supplement Number
    K122927 000