BEUDAMED
    FDA Registration Active 🇺🇸 United States

    12 Fr Heparin Two-Lumen Hemodialysis Catheterization Kit/Set

    Reg #: 3010041511 · FEI: 3010041511 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Teleflex LLC (NADC)
    Registration Number
    3010041511
    FEI Number
    3010041511
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    11245 N Distribution Cove
    City
    Olive Branch
    State
    MS
    ZIP
    38654
    Country
    US

    Regulatory Submissions

    510(k) Number
    K895417

    Owner / Operator

    Firm Name
    Teleflex
    Operator Number
    9062981
    Address
    3015 Carrington Mill Blvd.
    City
    Morrisville
    State
    NC
    Postal Code
    27560
    Country
    US
    Correspondent
    Divya Raman

    Products

    Device Name Product Code
    Catheter, Subclavian LFJ

    Proprietary Names

    12 Fr Heparin Two-Lumen Hemodialysis Catheterization Kit/Set Marked Spring-Wire Guide with Arrow Advancer 12 Fr. Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device