BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Michigan Critical Care Consultants, Inc.

    DI: 10854916006161 · Model: 5768 · MICHIGAN CRITICAL CARE CONSULTANTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Michigan Critical Care Consultants, Inc.
    Primary DI
    10854916006161
    Version / Model
    5768
    Company Name
    MICHIGAN CRITICAL CARE CONSULTANTS, INC.
    Labeler DUNS
    806687406
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    4
    Public Version Date
    2022-08-05
    Public Version Status
    Update
    Public Device Record Key
    d6962cfd-5e4a-44bd-b3c1-7b934386ffa2

    Device Description

    Soft Flow Aortic Catheter, Angled, Tip, Bulb, 7MM, NON VENTED

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

    GMDN Terms

    Code Name
    34893 Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial

    Identifiers

    Type ID
    Primary 10854916006161
    Package 20854916006175

    Customer Contacts

    Phone
    734-995-9089
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K132451 000