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    FDA UDI In Commercial Distribution 🇺🇸 United States

    TEG5000 HEMOSTASIS ANALYZER

    DI: 30812747018412 · Model: 07-066 · HAEMONETICS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TEG5000 HEMOSTASIS ANALYZER
    Primary DI
    30812747018412
    Version / Model
    07-066
    Company Name
    HAEMONETICS CORPORATION
    Labeler DUNS
    057827420
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-07-11
    Public Version
    4
    Public Version Date
    2023-10-02
    Public Version Status
    Update
    Public Device Record Key
    4eaa2b3a-4ff0-47c7-bffe-5a12de6d43ad

    Device Description

    TEG ANALYZER 5000, 230V, 60HZ, FG

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    JPA SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

    GMDN Terms

    Code Name
    66878 Blood viscoelasticity analyser IVD

    Identifiers

    Type ID
    Primary 30812747018412

    Customer Contacts

    Phone
    +1(800)-537-2802
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K993678 000