BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 00856825003036 · Model: 1020 · GALEMED CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    N/A
    Primary DI
    00856825003036
    Version / Model
    1020
    Company Name
    GALEMED CORPORATION
    Labeler DUNS
    656854379
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-04
    Public Version
    1
    Public Version Date
    2026-03-12
    Public Version Status
    New
    Public Device Record Key
    2640564f-90a0-4a71-8333-23e36c7430b9

    Device Description

    Babi.Plus NC pap Cannula Kit (4-7)

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BYE Attachment, Breathing, Positive End Expiratory Pressure

    GMDN Terms

    Code Name
    35202 Nasal oxygen cannula, CPAP

    Identifiers

    Type ID
    Package 00856825003166
    Primary 00856825003036

    Premarket Submissions

    Submission Number Supplement Number
    K090317 000