BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CPAP Tubing

    DI: 00819989011125 · Model: CPAP-TUBE-6FT-SPL-1 · EXCELERON MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CPAP Tubing
    Primary DI
    00819989011125
    Version / Model
    CPAP-TUBE-6FT-SPL-1
    Company Name
    EXCELERON MEDICAL, INC.
    Labeler DUNS
    825179992
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-23
    Public Version
    2
    Public Version Date
    2022-10-24
    Public Version Status
    Update
    Public Device Record Key
    9aa333da-b83e-4054-aeff-01512ab3edf6

    Device Description

    CPAP Tubing, 6 ft (Spirit Labeled), single-pack

    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
    Yes
    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
    BZO Set, Tubing And Support, Ventilator (W Harness)

    GMDN Terms

    Code Name
    37706 Ventilator breathing circuit, single-use

    Identifiers

    Type ID
    Primary 00819989011125
    Package 10819989011122