BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    MR Patient Care Temperature Sensor Jacket

    DI: 10884838111407 · Model: Temperature Sensor Jacket · Philips Medizin Systeme Böblingen GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

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    Basic Information

    Brand Name
    MR Patient Care Temperature Sensor Jacket
    Primary DI
    10884838111407
    Version / Model
    Temperature Sensor Jacket
    Catalog Number
    989803178181
    Company Name
    Philips Medizin Systeme Böblingen GmbH
    Labeler DUNS
    314101143
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2025-05-30
    Public Version
    2
    Public Version Date
    2026-01-07
    Public Version Status
    Update
    Public Device Record Key
    2483769f-957b-474e-8a5a-d3a4828b6b68
    Distribution End Date
    2025-08-11

    Device Description

    Disposable Flex Temp Jacket is designed for use with the FlexTEMP System, Sensor. The FlexTEMP Jacket must be used with the FlexTEMP Sensor while measuring Body temperature. This Sensor should also be used for surface temperature to reduce the occurrence of infection

    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
    MR Safe
    Direct Marking Exempt
    Yes
    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
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

    GMDN Terms

    Code Name
    13116 Electronic thermometer probe cover

    Identifiers

    Type ID
    Unit of Use 00884838111400
    Primary 10884838111407

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    -4 – 140 Degrees Fahrenheit
    Type
    Storage Environment Humidity
    Temperature Range
    5 – 80 Percent (%) Relative Humidity