BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Aerospray® Gram Slide Stainer/Cytocentrifuge

    DI: 03661540303951 · Model: Model 7322 · ELITECHGROUP INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Aerospray® Gram Slide Stainer/Cytocentrifuge
    Primary DI
    03661540303951
    Version / Model
    Model 7322
    Company Name
    ELITECHGROUP INC.
    Labeler DUNS
    052423787
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2021-02-23
    Public Version Status
    Update
    Public Device Record Key
    dbd53c6f-59fc-41a0-8450-2f995c84dd98

    Device Description

    The Aerospray Gram stainer is an in vitro diagnostic medical device for professional use only. The Gram stainer has been designed to perform automated Gram staining of pure strain isolate smears and human specimens with microorganisms for in vitro diagnostics with Elitech Group Gram reagents only.

    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
    Yes
    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
    KPA Slide Stainer, Automated

    GMDN Terms

    Code Name
    15599 Microscope slide stainer IVD

    Identifiers

    Type ID
    Primary 03661540303951

    Customer Contacts

    Phone
    1-800-453-2725
    Email
    [email protected]