FreezePoint® Freezing Point Osmometer is intended for laboratory use by qualified personnel for the determination of total osmolality of aqueous solutions.


Product Overview

FreezePoint® Freezing Point Osmometer is intended for laboratory use by qualified personnel for the determination of total osmolality of aqueous solutions.
FreezePoint® Freezing Point Osmometer - Model 6000


Device Description

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative determination of the osmotic concentration of a clinical specimen (e.g., urine, serum, tears, sweat) by comparing its freezing-point depression curve, or vapour-pressure depression curve, with that of a standard solution. It is often used to assess an abnormal osmolar ratio which may indicate disease [e.g., renal disease, diabetes insipidus, secretion of abnormal levels of antidiuretic hormone (ADH)].


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 80.00
    • N/A
  • Handling Environment Temperature - Degrees Celsius
    • 30.00
    • 10.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 80.00
    • N/A
  • Storage Environment Temperature - Degrees Celsius
    • 60.00
    • -10.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: JJM

    Device Name: Osmometer For Clinical Use

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: CH

    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: 862.2730

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 03661540304620

    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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