BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Model 9

    DI: B577910000 · Model: 9-10000 · SNAP DIAGNOSTICS LLC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Model 9
    Primary DI
    B577910000
    Version / Model
    9-10000
    Company Name
    SNAP DIAGNOSTICS LLC
    Labeler DUNS
    945853828
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-02-10
    Public Version
    2
    Public Version Date
    2026-02-19
    Public Version Status
    Update
    Public Device Record Key
    1bcd1c15-a3d3-45e7-ad47-94e32f9a608b

    Device Description

    The Snap Model 9 device is a wearable at home sleep recorder intended to record airflow, breathing effort and body position and is indicated for use and an aid for diagnostic evaluation of patient for sleep apnea and snoring.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    62230 Home-use sleep apnoea recording system

    Identifiers

    Type ID
    Primary B577910000