AccessGUDID - DEVICE: FreezePoint® Freezing Point Osmometer (03661540304712)

GUDID

Device Identifier (DI) Information

Brand Name: FreezePoint® Freezing Point Osmometer
Version or Model: Model 6000S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ELITECHGROUP INC.

Primary DI Number: 03661540304712
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052423787 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJM	Osmometer For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: less than 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: less than 80 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a7cef21e-0d11-4a81-9d87-4e7d2aa4d8ef
Public Version Date: September 16, 2022
Public Version Number: 2
DI Record Publish Date: February 17, 2021