BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OMNI™ II

    DI: 00810003380012 · Model: Programmer System (with OMNI Smart Software) · Impulse Dynamics (usa) Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OMNI™ II
    Primary DI
    00810003380012
    Version / Model
    Programmer System (with OMNI Smart Software)
    Catalog Number
    10-A604-3-US
    Company Name
    Impulse Dynamics (usa) Inc.
    Labeler DUNS
    878519342
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-12
    Public Version
    2
    Public Version Date
    2020-12-24
    Public Version Status
    Update
    Public Device Record Key
    c3d82dba-e3c9-4f38-a322-14725ced1b99

    Device Description

    OMNI™ II Programmer System (with OMNI Smart Software). System consists of: (1) OMNI II Programmer (with OMNI Smart Software) (1) OMNI II Programmer Tablet PC installed with OMNI Smart Programmer Software (1) OMNI II Programmer Interface Box (1) OMNI II Programmer Interface Box Cable (1) Medical-grade Ethernet isolator with Ethernet patch cable (1) OMNI II Programmer Wand (1) OMNI II Programmer Wand Extension Cable (1) USB to Serial Adapter Assembly (1) Single-lead (3-wire) ECG cable (1) Medical-grade Power Supply (1) Medical-grade Power Cord (1) Bluetooth printer with AC Adapter (2) Bluetooth printer paper rolls

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QFV Implantable Pulse Generator

    GMDN Terms

    Code Name
    47467 Cardiac contractility modulation system programmer

    Identifiers

    Type ID
    Primary 00810003380012

    Customer Contacts

    Phone
    845-359-2389
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P180036 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -4 – 158 Degrees Fahrenheit