BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ECMOtherm- II™

    DI: 30613994008702 · Model: 61399400870 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ECMOtherm- II™
    Primary DI
    30613994008702
    Version / Model
    61399400870
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-06-09
    Public Version
    4
    Public Version Date
    2019-12-11
    Public Version Status
    Update
    Public Device Record Key
    d92646ba-f092-4b29-8a28-245f6279fec0

    Device Description

    EXCHANGER 61399400870 1EA EMOTHRMII HT

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DTR HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

    GMDN Terms

    Code Name
    11973 Cardiopulmonary bypass system heat exchanger, reusable

    Identifiers

    Type ID
    Primary 30613994008702
    Package 50613994008706

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K884560 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – 50 Degrees Celsius