BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BlackBox RPM

    DI: B963BPM201W1 · Model: BPM-201W · 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
    B963BPM201W1
    Version / Model
    BPM-201W
    Company Name
    Blackbox Remote Patient Monitoring LLC
    Labeler DUNS
    117652799
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-12
    Public Version
    2
    Public Version Date
    2021-01-01
    Public Version Status
    Update
    Public Device Record Key
    1da0a14d-613f-4204-a6ee-c314bf66f7ed
    Distribution End Date
    2021-01-01

    Device Description

    Blood Pressure monitor designed to be used seamlessly with our proprietary hub or mobile app.

    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
    Yes
    Sterilization Methods
    High-level Disinfectant

    Product Codes

    Code Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

    GMDN Terms

    Code Name
    45617 Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

    Identifiers

    Type ID
    Primary B963BPM201W1
    Package BB1BB963201W1