BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    i-STAT

    DI: 00054749005208 · Model: 03P75-88 · ABBOTT POINT OF CARE INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    i-STAT
    Primary DI
    00054749005208
    Version / Model
    03P75-88
    Company Name
    ABBOTT POINT OF CARE INC.
    Labeler DUNS
    079226216
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-01
    Public Version
    4
    Public Version Date
    2023-10-18
    Public Version Status
    Update
    Public Device Record Key
    fe55750a-7513-485b-a1df-356881e48d72

    Device Description

    i-Stat 1 Wireless Analyzer

    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
    CGA Glucose Oxidase, Glucose

    GMDN Terms

    Code Name
    62181 Multiple clinical chemistry analyser IVD, point-of-care

    Identifiers

    Type ID
    Primary 00054749005208

    Customer Contacts

    Phone
    +1(800)366-8020
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K103195 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    16 – 46 Degrees Celsius