BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AirStrip ONE

    DI: B15320100 · Model: 2010 · Airstrip Technologies, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AirStrip ONE
    Primary DI
    B15320100
    Version / Model
    2010
    Company Name
    Airstrip Technologies, Inc.
    Labeler DUNS
    079232437
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-10-09
    Public Version
    6
    Public Version Date
    2023-08-02
    Public Version Status
    Update
    Public Device Record Key
    eedb9f86-d31f-4488-8473-55fd9d3f4609

    Device Description

    AirStrip Patient Monitoring - Client Web

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MSX System,Network And Communication,Physiological Monitors

    GMDN Terms

    Code Name
    66386 Bedside monitor remote-viewing software, physiological parameter

    Identifiers

    Type ID
    Primary B15320100

    Premarket Submissions

    Submission Number Supplement Number
    K160862 000