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 6000SP


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: 03661540304705

    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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