BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    nSpire Health

    DI: 10852417003689 · Model: KoKo Filter Kit · NSPIRE HEALTH, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

    Basic Information

    Brand Name
    nSpire Health
    Primary DI
    10852417003689
    Version / Model
    KoKo Filter Kit
    Catalog Number
    K022462
    Company Name
    NSPIRE HEALTH, INC.
    Labeler DUNS
    184817096
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    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
    ded738e0-3b3a-4a86-8ff3-4cd9263dfeb5

    Device Description

    KoKo Pulmonary Function Filter Kit, White with Rubber Mouthpiece for KoKo Px, HDpft and Collins PFT Systems.

    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
    BYP Mouthpiece, Breathing
    CAH Filter, Bacterial, Breathing-Circuit

    GMDN Terms

    Code Name
    60506 Pulmonary function testing kit

    Identifiers

    Type ID
    Primary 10852417003689
    Unit of Use 00852417003682