BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    STAT PROFILE

    DI: 00385480364591 · Model: CCX · NOVA BIOMEDICAL CORPORATION
    View on AccessGUDID
    Product Codes
    17
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    STAT PROFILE
    Primary DI
    00385480364591
    Version / Model
    CCX
    Catalog Number
    36459
    Company Name
    NOVA BIOMEDICAL CORPORATION
    Labeler DUNS
    070617139
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    8a045950-797f-4221-99b6-53ea35f1400a

    Device Description

    TUBING ASSEMBLIES L1, L2, L3 STP CCX

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CGA GLUCOSE OXIDASE, GLUCOSE
    CEM ELECTRODE, ION SPECIFIC, POTASSIUM
    CFA ELECTRODE, ION SPECIFIC, MAGNESIUM
    JGS ELECTRODE, ION SPECIFIC, SODIUM
    CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
    JKS Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide
    JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
    CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
    KHP ACID, LACTIC, ENZYMATIC METHOD
    CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
    GKR SYSTEM, HEMOGLOBIN, AUTOMATED
    CDS ELECTRODE, ION SPECIFIC, UREA NITROGEN
    JPK MIXTURE, HEMATOLOGY QUALITY CONTROL
    JFP ELECTRODE, ION SPECIFIC, CALCIUM
    JPI DEVICE, HEMATOCRIT MEASURING
    JJS CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
    GHS ASSAY, CARBOXYHEMOGLOBIN

    GMDN Terms

    Code Name
    56668 Metabolic profile clinical chemistry analyser IVD, portable, semi-automated

    Identifiers

    Type ID
    Primary 00385480364591

    Customer Contacts

    Phone
    +1(800)545-6682
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K061830 000