BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    nSpire Health

    DI: 10852417003719 · Model: KoKo Filter Kit · NSPIRE HEALTH, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    nSpire Health
    Primary DI
    10852417003719
    Version / Model
    KoKo Filter Kit
    Catalog Number
    831580
    Company Name
    NSPIRE HEALTH, INC.
    Labeler DUNS
    184817096
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    320ed79b-1856-4448-b3fc-9092ba4c54b7

    Device Description

    KoKo Standard White Filter Kit with Nose Clip and Rubber Mouthpiece 30mm ID x 34mm OD for use with most SensorMedics models. Box of 50.

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BXJ Clip, Nose
    BYP Mouthpiece, Breathing
    CAH Filter, Bacterial, Breathing-Circuit

    GMDN Terms

    Code Name
    60506 Pulmonary function testing kit

    Identifiers

    Type ID
    Primary 10852417003719
    Unit of Use 00852417003712