ScoutPro Osmolarity System

Basic Information

• Brand Name: ScoutPro Osmolarity System
• Primary DI: 00853539002188
• Version / Model: 100094
• Company Name: Tearlab Corporation
• Labeler DUNS: 155813749
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2022-12-06
• Public Version: 2
• Public Version Date: 2024-01-18
• Public Version Status: Update
• Public Device Record Key: 4009cb79-d026-46cd-a6f9-9de742172f92

Device Description

In-vitro analysis of ocular tear fluid.

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: Yes
• 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
OND	Osmolality Of Tears	Clinical Chemistry	862.1540	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
Unit of Use	10853539002185	GS1
Primary	00853539002188	GS1