BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Lipase NG OC Cal

    DI: 08058056682291 · Model: 04Y85-01 · SENTINEL CH. SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Lipase NG OC Cal
    Primary DI
    08058056682291
    Version / Model
    04Y85-01
    Catalog Number
    04Y85-01
    Company Name
    SENTINEL CH. SPA
    Labeler DUNS
    429572365
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-16
    Public Version
    1
    Public Version Date
    2019-04-24
    Public Version Status
    New
    Public Device Record Key
    bc01996a-853c-484c-8e7a-dfb4c70e7900

    Device Description

    Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitro Diagnostic use.

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JIT Calibrator, Secondary

    GMDN Terms

    Code Name
    53109 Lipase IVD, calibrator

    Identifiers

    Type ID
    Primary 08058056682291

    Customer Contacts

    Phone
    9999999999
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius