BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PeriWatch Vigilance® Cues™

    DI: B087PATT21011 · Model: 21.01.xx · PERIGEN SOLUTIONS LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PeriWatch Vigilance® Cues™
    Primary DI
    B087PATT21011
    Version / Model
    21.01.xx
    Company Name
    PERIGEN SOLUTIONS LTD
    Labeler DUNS
    533337713
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-07-21
    Public Version
    1
    Public Version Date
    2021-07-29
    Public Version Status
    New
    Public Device Record Key
    1393693a-1a8d-4067-88d4-e891fe8ff7fa

    Device Description

    PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.

    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
    HGM System, Monitoring, Perinatal

    GMDN Terms

    Code Name
    61956 Obstetrical monitoring/analysis software

    Identifiers

    Type ID
    Primary B087PATT21011

    Customer Contacts

    Phone
    8552364353
    Email
    [email protected]