BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Astra Spirometer

    DI: B279295202S1 · Model: 200 · S D I DIAGNOSTICS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Astra Spirometer
    Primary DI
    B279295202S1
    Version / Model
    200
    Catalog Number
    29-5202S
    Company Name
    S D I DIAGNOSTICS INC
    Labeler DUNS
    037690120
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-11
    Public Version
    6
    Public Version Date
    2022-03-08
    Public Version Status
    Update
    Public Device Record Key
    167c81f4-79b5-40c6-9448-c1adcc1b3b6f
    Distribution End Date
    2020-02-28

    Device Description

    Spirometer

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BZG Spirometer, Diagnostic

    GMDN Terms

    Code Name
    13680 Diagnostic spirometer, professional

    Identifiers

    Type ID
    Primary B279295202S1

    Premarket Submissions

    Submission Number Supplement Number
    K061571 000