FreezePoint® Freezing Point Osmometer

Basic Information

• Brand Name: FreezePoint® Freezing Point Osmometer
• Primary DI: 03661540304729
• Version / Model: Model 6000P
• Company Name: ELITECHGROUP INC.
• Labeler DUNS: 052423787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-17
• Public Version: 2
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: dcf400ec-2f81-4254-b5cb-f58938d04dac

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJM	Osmometer For Clinical Use	Clinical Chemistry	862.2730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57853	Osmometric analyser IVD	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)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03661540304729	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: – 80 Percent (%) Relative Humidity