BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Curved Insemina Intra Uterine Insemination Catheter Open Tip

    DI: 00819374021890 · Model: Curved Insemina Open Tip · ALLWIN MEDICAL DEVICES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Curved Insemina Intra Uterine Insemination Catheter Open Tip
    Primary DI
    00819374021890
    Version / Model
    Curved Insemina Open Tip
    Catalog Number
    I-IUI-C-O
    Company Name
    ALLWIN MEDICAL DEVICES, INC.
    Labeler DUNS
    796354509
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-18
    Public Version
    1
    Public Version Date
    2020-09-28
    Public Version Status
    New
    Public Device Record Key
    76d61fef-1454-4623-bbc8-bdd61a2c1fc6

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MFD Cannula, Intrauterine Insemination

    GMDN Terms

    Code Name
    45846 Assisted reproduction transfer catheter/set

    Identifiers

    Type ID
    Package 10819374021897
    Primary 00819374021890

    Premarket Submissions

    Submission Number Supplement Number
    K190522 000