BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Egress Safety Catheter

    Reg #: 3027547323 · FEI: 3027547323 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    InnoCare Urologics
    Registration Number
    3027547323
    FEI Number
    3027547323
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7175 SW 47TH STREET, Suite 207
    City
    Miami
    State
    FL
    ZIP
    33155
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241424

    Owner / Operator

    Firm Name
    InnoCare Urologics
    Operator Number
    10088357
    Address
    7175 SW 47TH STREET, Suite 207
    City
    Miami
    State
    FL
    Postal Code
    33155
    Country
    US
    Correspondent
    Patrick McCain

    Products

    Device Name Product Code
    Catheter, Retention Type, Balloon EZL
    Foley Catheters And Accessories With Additional Safety Features SCT

    Proprietary Names

    Egress Safety Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility