ScoutPro Osmolarity System

GUDID 10853539002185

In-vitro analysis of ocular tear fluid.

Tearlab Corporation

Osmometric analyser IVD

• Primary Device ID: 10853539002185
• NIH Device Record Key: 4009cb79-d026-46cd-a6f9-9de742172f92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScoutPro Osmolarity System
• Version Model Number: 100094
• Company DUNS: 155813749
• Company Name: Tearlab Corporation
• Device Count: 200
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853539002188 [Primary]
GS1	10853539002185 [Unit of Use]

FDA Product Code

• OND: Osmolality Of Tears

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-14
• Device Publish Date: 2022-12-06

Devices Manufactured by Tearlab Corporation

• 00853539002034 - TearLab Osmolarity Test Card: 2025-09-05
• 10853539002048 - Osmolarity Normal Control Solutions: 2024-01-15
• 10853539002055 - Osmolarity High Control Solution: 2024-01-15
• 10853539002185 - ScoutPro Osmolarity System: 2022-12-14In-vitro analysis of ocular tear fluid.
• 10853539002185 - ScoutPro Osmolarity System: 2022-12-14 In-vitro analysis of ocular tear fluid.