BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Affirm™ VPIII Ambient Temperature Transfer System

    Reg #: 3013160357 · FEI: 3013160357 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    RR Donnelley Global Turnkey Solutions
    Registration Number
    3013160357
    FEI Number
    3013160357
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Blvd Internacional 881, San Jeronimo, CD
    City
    Juarez Chihuahua
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K920536

    Owner / Operator

    Firm Name
    RR Donnelley Global Turnkey Solutions
    Operator Number
    10052247
    Address
    6315 W BY NORTHWEST BLVD
    City
    Houston
    State
    TX
    Postal Code
    77040
    Country
    US
    Correspondent
    Lee Rush

    US Agent

    Business Name
    RR Donnelley
    Contact Name
    Lee Rush
    Address
    6315 North by Northwest Blvd., Houston
    City
    Houston
    State
    TX
    ZIP
    77040
    Country
    US
    Email
    [email protected]
    Phone
    979 4841734

    Products

    Device Name Product Code
    Device, Specimen Collection LIO

    Proprietary Names

    Affirm™ VPIII Ambient Temperature Transfer System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device