BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Avoximeter Whole Blood CO-Oximeter

    DI: 10711234530054 · Model: AVOX4000 · ACCRIVA DIAGNOSTICS HOLDINGS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Avoximeter Whole Blood CO-Oximeter
    Primary DI
    10711234530054
    Version / Model
    AVOX4000
    Catalog Number
    AVOX4000
    Company Name
    ACCRIVA DIAGNOSTICS HOLDINGS, INC.
    Labeler DUNS
    079299318
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-22
    Public Version
    5
    Public Version Date
    2022-08-31
    Public Version Status
    Update
    Public Device Record Key
    a750aa02-0df8-4aec-a0f1-647a6e76b83c

    Device Description

    Avoximeter Whole Blood CO-Oximeter System - Instrument

    Device Characteristics

    Single Use
    No
    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
    Yes
    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
    JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide

    GMDN Terms

    Code Name
    56673 Co-oximetry analyser IVD, point-of-care

    Identifiers

    Type ID
    Primary 10711234530054

    Customer Contacts

    Phone
    1-800-678-0710
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K951485 000