BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Bolus - US

    DI: 17290109150038 · Model: 15071-000-0005 · EITAN MEDICAL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Bolus - US
    Primary DI
    17290109150038
    Version / Model
    15071-000-0005
    Catalog Number
    15071-000-0005
    Company Name
    EITAN MEDICAL LTD
    Labeler DUNS
    533108028
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-07
    Public Version
    5
    Public Version Date
    2022-11-23
    Public Version Status
    Update
    Public Device Record Key
    7bb6789a-2e8d-4ca0-8bf3-f2b6ec4be929
    Distribution End Date
    2017-03-03

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MRZ Accessories, Pump, Infusion

    GMDN Terms

    Code Name
    35465 Assistive remote control

    Identifiers

    Type ID
    Direct Marking 07290109150031
    Package 27290109150035
    Primary 17290109150038

    Customer Contacts

    Phone
    1-800-241-4002
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K123049 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -40 – 70 Degrees Celsius