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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Life Warmer Quantum Blood and Fluid Warming System

    DI: 00868058000485 · Model: 63-5900 · LIFE WARMER INC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Life Warmer Quantum Blood and Fluid Warming System
    Primary DI
    00868058000485
    Version / Model
    63-5900
    Catalog Number
    35-0006
    Company Name
    LIFE WARMER INC
    Labeler DUNS
    032045686
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-03
    Public Version
    2
    Public Version Date
    2022-03-22
    Public Version Status
    Update
    Public Device Record Key
    8bf8852e-10ec-4449-ac24-fb0e63ecba33

    Device Description

    The Quantum Blood and Fluid Warming System from LifeWarmer is a Game-Changing innovation that has succeeded in closing a critical capability gap previously left exposed by other commercial off-the-shelf fluid warmers currently fielded. Size, weight, performance, and ease of use are no longer collective barriers to the delivery of whole blood in far forward and near point of injury (POI) prehospital casualty management. The Quantum exceeds all healthcare and logistical requirements for the delivery of warmed blood or fluids across the defined spectrum of care. The system consists of unique thermal administration sets that incorporate sensing elements with an integrated heating system that does not disrupt the fluid path. With advanced intelligence throughout the system, the lightweight Controller modulates and moderates the energy flow to the integrated heating elements to ensure consistent normothermic fluid delivery to the casualty. The 44V battery is the smallest in category, able to rapidly adjust power distribution based on the temperature and flow rate of the input fluid. This creates a highly efficient system capable of previously unrealized performance optimizations. The Quantum system has an operational weight of just 22 total ounces yet can deliver two units of 39°F Whole Blood (WB) at 100mL/min with an output temperature of 100.4°F (38°+/- 2°C) with only a 24 second warm-up period. The Quantum Blood and Fluid Warming System provides the Tactical Health Care Professional with significant technological overmatch in the fight to eliminate preventable combat death. Quantum System Contents: 1 x Controller 1 x Battery 1 x Battery Charger 2 x TTS-B (Thermal Transfusion Set - Blood) NOTE: TTS-B is Single Use Only, Supplied sterile via Ethylene Oxide

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    MR Unsafe
    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
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LGZ Warmer, Thermal, Infusion Fluid
    BSB Warmer, Blood, Non-Electromagnetic Radiation

    GMDN Terms

    Code Name
    47616 Conduction blood/fluid warmer

    Identifiers

    Type ID
    Primary 00868058000485

    Premarket Submissions

    Submission Number Supplement Number
    K181775 000