BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ivWatch Patient Cable

    DI: 00814088020115 · Model: Model 400 · IVWATCH, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ivWatch Patient Cable
    Primary DI
    00814088020115
    Version / Model
    Model 400
    Catalog Number
    00814088020115
    Company Name
    IVWATCH, LLC
    Labeler DUNS
    057028415
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-17
    Public Version
    1
    Public Version Date
    2020-07-27
    Public Version Status
    New
    Public Device Record Key
    8d6e9263-6ec0-4ff5-9f98-13431e77a46a

    Device Description

    Reusable, Electronic Patient Cable

    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
    MR Unsafe
    Direct Marking Exempt
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PMS Peripheral Intravenous (Piv) Infiltration Monitor

    GMDN Terms

    Code Name
    47487 Electrical-only medical device connection cable, reusable

    Identifiers

    Type ID
    Primary 00814088020115

    Customer Contacts

    Phone
    757-705-2461
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K192385 000

    Device Sizes

    Type Value Unit Text
    Weight .21 Pound
    Length 144 Inch