- Physicians Office Resource

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 6000P

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: 03661540304729

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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