BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    3B Medical, Inc.

    DI: 00853041003222 · Model: RO1000 · 3B MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    3B Medical, Inc.
    Primary DI
    00853041003222
    Version / Model
    RO1000
    Company Name
    3B MEDICAL, INC.
    Labeler DUNS
    078517316
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-18
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    964c3aca-3067-4830-9363-f81bb131718f

    Device Description

    3B Medical, Inc's Rio Nasal Pillow Mask All Size Kit includes the nasal mask, headgear and nasal pillow cushions in small, medium and large This mask is for use with a CPAP or bi-level machine.

    Device Characteristics

    Single Use
    No
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BZD Ventilator, Non-Continuous (Respirator)

    GMDN Terms

    Code Name
    57815 CPAP/BPAP nasal mask, reusable

    Identifiers

    Type ID
    Primary 00853041003222