Mul-T-Blanket


Product Overview

Mul-T-Blanket - 8001-061-612


Device Description

An underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated, as part of an external circulating-fluid core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric). It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device.


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 10.00
  • Handling Environment Temperature - Degrees Fahrenheit
    • 140.00
    • -40.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 10.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 140.00
    • -40.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DWJ

    Device Name: System, Thermal Regulating

    Device Class: 2

    Physical State: N/A

    Definition: If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

    Submission Type ID: 1

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 870.5900

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 57613327175351

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 07613327175356

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: case


    Device Id: 07613327175356

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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