BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Hydrogel Adhesive Strap

    DI: 00627987360110 · Model: FP120-FOT01-003 · 1929803 Ontario Corp
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Hydrogel Adhesive Strap
    Primary DI
    00627987360110
    Version / Model
    FP120-FOT01-003
    Company Name
    1929803 Ontario Corp
    Labeler DUNS
    204195374
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-06-17
    Public Version
    2
    Public Version Date
    2023-11-03
    Public Version Status
    Update
    Public Device Record Key
    7f700a65-1628-42bc-b3ce-e36753334528

    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
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DPW Flowmeter, Blood, Cardiovascular

    GMDN Terms

    Code Name
    36970 Noninvasive vascular ultrasound system probe

    Identifiers

    Type ID
    Package 10627987360117
    Primary 00627987360110

    Customer Contacts

    Phone
    2899982982
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K200337 000