BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BlackBox RPM

    DI: B963PO401W1 · Model: PO-401W · Blackbox Remote Patient Monitoring LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BlackBox RPM
    Primary DI
    B963PO401W1
    Version / Model
    PO-401W
    Company Name
    Blackbox Remote Patient Monitoring LLC
    Labeler DUNS
    117652799
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-20
    Public Version
    2
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    74eb60f4-4dc4-4af2-9526-6862ff02b877

    Device Description

    Pulse Oximeter

    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
    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
    DQA Oximeter

    GMDN Terms

    Code Name
    45607 Pulse oximeter

    Identifiers

    Type ID
    Package BB4B963PO401W1
    Primary B963PO401W1

    Premarket Submissions

    Submission Number Supplement Number
    K120502 000