BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Bulb Trans Ultra Embryo Transfer Catheter

    DI: 00812261016832 · Model: Bulb Trans Ultra · ALLWIN MEDICAL DEVICES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Bulb Trans Ultra Embryo Transfer Catheter
    Primary DI
    00812261016832
    Version / Model
    Bulb Trans Ultra
    Catalog Number
    BT-ETC-U
    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
    ac17fcca-8353-40f7-9a5a-62b9d28a110b

    Device Description

    Bulb Trans Ultra Embryo Transfer Catheter - Bulb Tip

    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
    MQF Catheter, Assisted Reproduction

    GMDN Terms

    Code Name
    45846 Assisted reproduction transfer catheter/set

    Identifiers

    Type ID
    Package 10812261016839
    Primary 00812261016832

    Customer Contacts

    Phone
    714-572-1709
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K200248 000